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Title:
FOAMED EDIBLE COMPOSITION COMPRISING CAFFEINE
Document Type and Number:
WIPO Patent Application WO/2014/053310
Kind Code:
A1
Abstract:
The present invention provides a foamed edible product comprising caffeine, and preferably also taurine. The product can be used to provide caffeine in an amount sufficient to provide a boosting of mental and/or physical energy and/or alertness, while limiting the risk of overdosing caffeine.

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Inventors:
ABRAHAMSE SALOMON LEENDERT (NL)
BLOM WILHELMINA ALBERTHA (NL)
MELA DAVID JASON (NL)
PETERS HENRICUS PETRUS (NL)
QUINLAN PAUL THOMAS (GB)
TAPPER JAY PHILIP (US)
Application Number:
PCT/EP2013/069261
Publication Date:
April 10, 2014
Filing Date:
September 17, 2013
Export Citation:
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Assignee:
UNILEVER NV (NL)
UNILEVER PLC (GB)
CONOPCO INC DBA UNILEVER (US)
International Classes:
A23L2/00; A23L2/52; A23P30/40
Domestic Patent References:
WO2008046729A12008-04-24
WO2008009623A12008-01-24
WO2008046729A12008-04-24
WO2013004479A12013-01-10
WO2008046699A12008-04-24
Foreign References:
US20060147602A12006-07-06
US20060147602A12006-07-06
US5456677A1995-10-10
US20100009052A12010-01-14
Other References:
BOULBY, P.; P. GOWLAND; V. ADAMS; R.C. SPILLER: "Use of echo planar imaging to demonstrate the effect of posture on the intragastric distribution and emptying of an oil/water meal", NEUROGASTROENTEROLOGY AND MOTILITY, vol. 9, no. 1, 1997, pages 41 - 47
FEDOROFF I; POLIVY J; HERMAN CP: "The specificity of restrained versus unrestrained eaters' responses to food cues: general desire to eat, or craving for the cued food?", APPETITE, vol. 41, no. 1, 2003, pages 7 - 13
FEINLE, C.; P. KUNZ; P. BOESIGER; M. FRIED; W. SCHWIZER: "Scintigraphic validation of a magnetic resonance imaging method to study gastric emptying of a solid meal in humans", GUT, vol. 44, no. 1, 1999, pages 106 - 111
FLINT A; RABEN A; BLUNDELL JE; ASTRUP A: "Reproducibility, power and validity of visual analogue scares in assessment of appetite sensations in single test meal studies", INTERNATIONAL JOURNAL OF OBESITY, vol. 24, 2000, pages 38 - 48
GROOT DE, P. W. N.; KOVACS, E. M. R.; MELNIKOV, S. M.; MONFERRER, J.; STOYANOV, S. S.: "The effects of gas-filled liquid foods on appetite", INTERNATIONAL JOURNAL OF OBESITY, vol. 32, 2008, pages S83
GRAY, R. W.; FRENCH, S. J.; ROBINSON, T. M.; YEOMANS, M. R.: "Dissociation of the effects of preload volume and energy content on subjective appetite and food intake", PHYSIOLOGY & BEHAVIOR, vol. 76, 2002, pages 57 - 64
MONSIVAIS, P.; PERRIGUE, M. M.; DREWNOWSKI, A.: "Sugars and satiety: does the type of sweetener make a difference?", AMERICAN JOURNAL OF CLINICAL NUTRITION, vol. 86, 2007, pages 116 - 123
MORGAN JF; REID F; LACEY JH: "The SCOFF questionnaire: assessment of a new screening tool for eating disorders", BR MED J, vol. 319, 1999, pages 1467 - 1468
OSTERHOLT KM; ROE LS; ROLLS BJ: "Incorporation of air into a snack food reduces energy intake", APPETITE, vol. 48, 2007, pages 351 - 8
PETERS HPF; FOLTZ M; KOVACS EMR; MELA DJ; SCHURING EAH; WISEMAN SA: "The effect of protease inhibitors derived from potato formulated in a minidrink on appetite, food intake and plasma cholecystokinin levels in humans", INT J OBESITY, vol. 35, 2011, pages 244 - 250
POLIVY J; HERMAN CP; WARSH S: "Internal and external components of emotionality in restrained and unrestrained eaters", J ABNORMAL PSYCHOL, vol. 87, 1978, pages 497 - 504
ROLLS BJ; BELL EA; WAUGH BA: "Increasing the volume of a food by incorporating air affects satiety in men", AM J CLIN NUTR, vol. 72, 2000, pages 361 - 8
SCHURING E; QUADT F; KOVACS EM; MEULLENET JF; WISEMAN S; MELA DJ, APPETITE, vol. 59, 2012, pages 601 - 9
SCHWIZER, W.; R. FRASER; H. MAECKE; K. SIEBOLD; R. FUNCK; M. FRIED: "Gd-DOTA as a gastrointestinal contrast agent for gastric emptying measurements with MRI", MAGNETIC RESONANCE IN MEDICINE, vol. 31, no. 4, 1994, pages 388 - 393
STRATTON RJ; STUBBS RJ; HUGHES D; KING N; BLUNDELL JE; ELIA M: "Comparison of the traditional paper visual analogue scale questionnaire with an Apple Newton electronic appetite rating system (EARS) in free living subjects feeding ad libitum", EUROPEAN JOURNAL OF CLINICAL NUTRITION, vol. 52, 1998, pages 737 - 41
STUBBS RJ; HUGHES DA; JOHNSTONE AM ET AL.: "The use of visual analogue scales to assess motivation to eat in human subjects: a review of their reliability and validity with an evaluation of new hand-held computerized systems for temporal tracking of appetite ratings", BRITISH JOURNAL OF NUTRITION, vol. 84, 2000, pages 405 - 15
Attorney, Agent or Firm:
VAN BENTHUM, Wilhelmus, A, J. (Olivier van Noortlaan 120, AT Vlaardingen, NL)
Download PDF:
Claims:
Claims

1. Foamed edible product comprising a continuous phase and dispersed therein a gaseous phase, the product having an overrun of at least 50%, preferably at least 100%, which product comprises caffeine in an amount of 0.2 - 20 mg per ml of aerated product.

2. Foamed product according to claim 1 , which comprises caffeine in an amount of 0.3 to 15 mg per ml of aerated product, preferably 0.5 to 10 mg aerated product.

3. Foamed product according to claim 1 or 2, wherein the product further comprises taurine, in a weight ratio caffeine : taurine of from 1 : 5 to 1 : 40.

4. Foamed product according to any of the preceding claims, wherein the product has a liquid or pourable consistency.

5. Foamed product according to any of the preceding claims, wherein the continuous phase is liquid.

6. Foamed product according to any of the preceding claims, wherein the continuous phase comprises a foaming agent and a stabilizer.

7. Foamed product according to any of the preceding claims, wherein the product is characterised by a high in-mouth foam stability being evidenced by a reduction in overrun of less than 35% under in-mouth conditions, using the methodology defined in the description.

8. Pressurised container holding an edible liquid and a propellant, which liquid can be released from the container by activating a valve to produce an edible foam product, said edible foam product having an overrun of at least 50%, preferably at least 100%, wherein the edible liquid comprises water in an amount of from 50 to 99.5% by weight and caffeine in an amount of from 0.2 to 40 mg per g of edible liquid.

9. Pressurised container according to claim 8, wherein the amount of caffeine is from 0.4 to 20 mg per g of edible liquid.

10. Pressurised container according to claim 8 or 9, wherein the edible liquid further comprises taurine, in a weight ratio caffeine : taurine of from 1 : 5 to 1 : 40.

1 1. Pressurised container according to any of claim 8 to 10, wherein the edible liquid further comprises a foaming agent and a stabilizer.

12. Pressurised container according to any of claims 8 to 1 1 , wherein the amount of liquid in the container is 10-500 ml, preferably 20 to 250 ml.

13. Use of a foamed edible product according to any of claims 1 to 7, for improving mental and/or physical alertness or energy.

14. Use according to claim 13, by ingesting 10 to 300 ml of the foamed edible product, preferably ingesting at least 50 ml, more preferably at least 75 ml, even more preferably at least 100 ml.

15. Foamed product according to any of claims 1 to 7 for use in improving mental and/or physical alertness and/or energy.

16. Foamed product according to claim 15 for use in improving mental and/or physical alertness and/or energy, by ingesting 10 to 300 ml of the foamed edible product of this invention, preferably ingesting at least 50 ml, more preferably at least 75 ml, even more preferably at least 100 ml.

17. Method for providing caffeine in an amount sufficient to provide a boosting of mental and/or physical energy and/or alertness,

whilst such method simultaneously limits tendency to overdosing of caffeine,

which method relates to ingesting a foamed edible product comprising a continuous phase and dispersed therein a gaseous phase,

the product having an overrun of at least 50%, preferably at least 100%,

which product comprises caffeine in an amount of 0.2 - 20 mg per ml of aerated product, and which product is characterised by

a high in-mouth foam stability being evidenced by a reduction in overrun of less than 35% under in-mouth conditions, using the methodology defined in the description.

Description:
FOAMED EDIBLE COMPOSITION COMPRISING CAFFEINE Introduction

The present invention relates to a foamed edible composition, which composition comprises caffeine, and optionally taurine. The invention further relates to the use of such foamed composition for improving mental and/or physical alertness and/or energy, by ingesting such foam. The invention further relates to pressurized containers for providing such foamed edible composition. Background of the invention

Coffee is a beverage known to contain caffeine, in amounts sufficient to have a physiological effect upon ingestion of commonly accepted amounts of coffee beverage. Such effects are believed to relate to e.g. mental and/or physical alertness and/or (feelings of) energy. For such (and other reasons) coffee is consumed by many people.

The amounts of caffeine in coffee beverages depend on many factors, but can e.g. be around 60-150 mg per cup. Tea and chocolate beverages (and other less widely known vegetable extracts) also contain caffeine, but usually less than coffee. Other well -known caffeine-containing beverages are cola's, such as sold under trademarks of the manufacturers Coca Cola and Pepsi (a 330 ml portion of such often contains about 30-50 mg of caffeine). At high dosages, caffeine may lead to one or more symptoms of restlessness, fidgeting, anxiety, tremor, jitter, increased heart rate, heart palpitations, sweating, and other. Since several decades soft drink-like beverages are marketed aimed at boosting or providing energy and/or alertness, in a mental and/or physical way. Well-known examples which exist since the 1980's are beverages sold under the Red Bull trademark. Similar products exist, although usually sold in smaller numbers, such as Monster Energy drink, Rockstar energy drink, SoBe Energy Rush, Rush energy drink, and many others (for short herein abbreviated and generalized as "energy drinks"). Drinks like these usually contain per portion (e.g. 250 to 330 ml) 70-100 mg caffeine. Other ingredients include common soft drink ingredients like water, flavourings and sweetener (sugar and/or low-calory sweeting agents) one or more other ingredients which (next to caffeine) are believed to be stimulants of (perceived) energy levels and/or alertness, such as taurine,

glucuronolactone, and guarana. Given the high level of caffeine in these products compared to drinks which are traditionally seen as thirst quenchers (e.g. Coca Cola and Pepsi Cola) and the effects caffeine may cause when ingested in high amounts, these energy drinks should preferably not be seen and used as thirst quenchers, but used in moderation (that is: preferably not too many units of such energy drinks in a short time frame, e.g. only one per a few hours). This is not easy for the average consumer, as in packaging (can), appearance (fizzy drink, often dark-colored) and taste they usually seem to fit in the same category as e.g. cola- drinks like those marketed by Coca Cola and Pepsi, yet they contain far higher levels of caffeine, which may easily lead to dosings which are undesirably high in a short time frame. Put in other words: someone who is a regular consumer of an energy product like that of Red Bull, may, e.g. when he or she is thirsty, start consuming multiple units of such energy shot, as if it were e.g. products like cola-beverages. This may lead to caffeine overdosing, which although not dangerous as such, it may be unpleasant for the user, may lead to unsafe situations (e.g. anxiety and tremor with those handling equipment like cars, trucks, and other heavy machinery), and will not provide optimal results for which the beverage was consumed initially.

US 2006/147602 A1 discloses a carbonated protein beverage, containing caffeine.

US 5,456,677 discloses spray pump devices that can spray as a liquid spray or stream its contents directly in the mouth. The composition contains caffeine and a breath freshener to mask the taste of caffeine. Metered dosings are 0.1-0.2 ml per delivery dose.

US 2010/0009052 discloses compositions containing dissolved gasses, which

compositions are offered for use to provide foamed beverages. WO 2008/009623 discloses an apparatus for making a foam having a controlled gas bubble size distribution in a liquid matrix.

WO 2008/046729 discloses that aerated edible products can be used to induce satiety. Non-pre-published patent application WO 2013/004479 A1 discloses that even small volumes of aerated products such as those referred to in WO 2008/046729, as small as 50 ml, may provide a satiety effect.

Summary of the invention

Hence, there is a need for an product that provides a similar amount of stimulation of energy or alertness (mentally and/or physically) yet which is formulated in such a way that it has a reduced tendency to lead to over-consumption when compared to the energy drinks now available.

It has now been found that such may be achieved, at least in part, by a foamed edible product comprising a continuous phase and dispersed therein a gaseous phase, the product having an overrun of at least 50%, preferably at least 100%, which product comprises caffeine in an amount of 0.2 - 20 mg per ml of aerated product.

The invention further relates to a convenient way to prepare or provide such foamed edible product, being by expelling from a pressurised can. Hence, the invention further relates to a pressurised container holding an edible liquid and a propellant, which liquid can be released from the container by activating a valve to produce an edible foam product, said edible foam product having an overrun of at least 50%, preferably at least 100%, wherein the edible liquid comprises water in an amount of from 50 to 99.5% by weight and caffeine in an amount of from 0.2 to 40 (preferably 0.4 to 20) mg per g of edible liquid.

The invention further relates to the use of a foamed edible product according to this invention for improving mental and/or physical alertness or energy.

Detailed description

"Foam", "foamed composition", "foam product" and "aerated composition" are herein used interchangeably: they mean herein the same. "Aerated" does not imply that the gas bubbles dispersed in the continuous liquid phase is air or has the same composition as air. An aerated composition, like a foam, foam product or foamed composition herein, can have any gas as specified herein dispersed as bubbles in the continuous liquid phase. Aerated or foamed means the presence of a compound in gas phase at temperatures of between 1 and 40°C and atmospheric pressure, wherein the gas can be air but also other gaseous compounds (i.e. aerated can be with other cases than air).

"Overrun" of a foamed product is calculated using the following equation:

Overrun = 100% x (V foam product - V mix ) / V mix Vfoam roduct = Volume of a sample of the edible foamed product

V mix = Volume of the same sample after the dispersed gas phase has been removed. It is believed that caffeine can easily be included in edible foam products according to this invention, and in particular that caffeine can be included in edible foam products that are already known to be able to induce satiety, such as those disclosed in

WO 2013/004479 A1. It is also believed that the caffeine (at the concentration level that is here at issue) does not affect the foaming behavior (e.g. foam stability) to such an extent that it may influence the satiety effect the foam may have. Consequently, the present invention provides a composition which can boost or improve mental and/or physical energy or alertness, yet which composition is in such a format that the consumer is less likely to be inclined to consume more (in comparison to an amount of a commercial energy drink that provides the same amount of caffeine) than the recommended dosing (e.g. corresponding to 50-100 mg caffeine per dosing moment, whereby dosing moments are typically 2-4 hours apart). It is believed that the satiety induced by a sufficient amount of foam reduces the tendency of individuals to consider the energy shot as a thirst quencher, and the latter could easily lead to overdosing, which danger is thus reduced by the present invention. Additionally, it is believed that the foam as a format for ingestion as such reduces the tendency of the product to be seen as a thirst quencher, which allows even smaller volumes of foam for the present invention. In the present invention, to provide a good yet safe effect, it is preferred that the foamed product according to the present invention comprises caffeine in an amount of 0.3 to 15 mg per ml of aerated product, preferably 0.5 to 10 mg aerated product.

Next to caffeine, other components may be present which are considered or believed to be a stimulant for mental and/or physical alertness or energy. Hence, it may be preferred that the foamed composition of the present invention further comprises taurine. When taurine is present, it is preferred that the amount of taurine is such that the weight ratio caffeine : taurine is from 1 : 5 to 1 : 40, more preferably from 1 : 8 to 1 : 25. Likewise, it may be preferred that the invention comprises glucuronolactone. When such is present, the amount of glucoronolactone is preferably such that caffeine and glucoronolactone are present in a weight ratio of from 1 : 2 to 1 : 25. Likewise, the invention may further comprise guarana. When guarana is present such is preferably in a weight ratio caffeine to guarana of from 1 : 5 to 1 : 100. It may also be preferred, e.g. for reasons of image, taste or efficacy that the products according to this invention and in its use comprise caffeine and taurine and guarana (in the ratio's as disclosed above), or similarly it may be preferred for the same reasons that the products according to this invention and in its use comprise caffeine and taurine and glucoronolactone (in the ratio's as disclosed above).

For ease of consumption, the foamed edible product according to the present invention preferably has a liquid or pourable consistency. E.g. to achieve such, but also to facilitate preparation of the foam, it is preferred for the compositions herein that the continuous phase (of the foamed edible composition) is a liquid.

The continuous liquid phase in the foamed composition according to the invention preferably comprises (by weight, based on the total composition) 50-99.5% water, more preferably from 70-99% water.

Further ingredients preferably include components to facilitate formation and/or maintenance of the foam. Hence, it may be preferred that the continuous phase comprises a foaming agent (in an amount of from 1 to 7% by weight in case such foaming agent is a food grade proteins, and amount of from 0.2 to 2% for other non-protein foaming agents) a and a stabilizer (preferably from 0.1 to 5% by weight), such as those exemplified further in this document. As the foam does not appear to the consumer as a beverage, it is believed it does not make the impression to the user as a thirst quencher, and hence small volumes of foam may be used (provided that they are concentrated enough in terms of caffeine) as a vehicle of caffeine, which still reduce the tendency to overdosing when consumers see products like Red Bull as a thirst quencher. Hence, the present invention further relates to the use of the compositions of the present invention for improving mental and/or physical alertness and/or energy, by ingesting 10 to 300 ml of the foamed edible product of this invention. When wishing to rely on a proven satiety effect, however, as a means to reduce the tendency to overdosing, a minimum amount of foam is required: at least 50 ml, preferably at least 75 ml, more preferably at least 100 ml, and the foam should have sufficient stability as expressed as a high in-mouth foam stability being evidenced by a reduction in overrun of less than 35% under in-mouth conditions, using the methodology defined herein below. Therefore preferably the present invention provides use of the compositions of the present invention for improving mental and/or physical alertness and/or energy, by ingesting 10 to 300 ml of the foamed edible product of this invention, preferably ingesting at least 50 ml, more preferably at least 75 ml, even more preferably at least 100 ml. The present invention also relates to the composition of the present invention for use in improving mental and/or physical alertness and/or energy. Preferably 10 to 300 ml of the foamed edible product of this invention are ingested, preferably at least 50 ml, more preferably at least 75 ml, even more preferably at least 100 ml of the compositions.

The present invention also relates to a method for improving mental and/or physical alertness or energy, by ingesting the compositions of the invention. Preferably 10 to 300 ml of the foamed edible product of this invention are ingested, preferably at least 50 ml, more preferably at least 75 ml, even more preferably at least 100 ml of the compositions.

The present invention also relates to a method for providing caffeine in an amount sufficient to provide a boosting of mental and/or physical energy and/or alertness, whilst such method simultaneously limits tendency to overdosing of caffeine,

which method relates to ingesting a foamed edible product comprising a continuous phase and dispersed therein a gaseous phase,

the product having an overrun of at least 50%, preferably at least 100%,

which product comprises caffeine in an amount of 0.2 - 20 mg per ml of aerated product, and which product is characterised by

a high in-mouth foam stability being evidenced by a reduction in overrun of less than 35% under in-mouth conditions, using the methodology defined herein.

The present invention also relates to the composition of the present invention for use in a method for providing caffeine in an amount sufficient to provide a boosting of mental and/or physical energy and/or alertness,

whilst such method simultaneously limits tendency to overdosing of caffeine,

which method relates to ingesting a foamed edible product comprising a continuous phase and dispersed therein a gaseous phase,

the product having an overrun of at least 50%, preferably at least 100%,

which product comprises caffeine in an amount of 0.2 - 20 mg per ml of aerated product, and which product is characterised by

a high in-mouth foam stability being evidenced by a reduction in overrun of less than 35% under in-mouth conditions, using the methodology defined herein. The benefits of the present invention may be obtained with any type of edible foamed composition as specified for the composition according to this invention and for the method and uses of this invention, as long as it has sufficient foam stability in the mouth. It is believed in the context of this invention that if a foam has sufficient stability in the mouth, such foam will also have sufficient stability in the esophagus and stomach to yield the advantages herein described. "Sufficient foam stability in the mouth" is herein defined 5 as a reduction in overrun of less than 35% when a sample of the product is subjected to a stability test in which conditions of shear are applied that are similar to those observed in the mouth. The in-mouth stability of a foam composition of the present invention and in its methods and uses can be determined by introducing a predetermined volume of an edible aerated product in a glass funnel (diameter 100 mm, neck length 100 mm, neck diameter

10 10 mm), which is connected to a silicone tube (length 400 mm, diameter 12x8 mm). The middle part of the silicone tube is inserted into a peristaltic pump (e.g. a Verderflex 2010, Verder Ltd, Leeds, UK) operating at 60 rpm. After the processing in the peristaltic pump the sample is collected in a glass measuring cylinder and the product volume and product weight are measured immediately. In the shear test described above the foam products in

15 the methods and uses of the present invention typically show a reduction in overrun of less than 30%, preferably of less than 25%, most preferably of less than 22%. In contrast, known edible foam products, such as whipped cream, show decreases in overrun that are well in excess of these percentages.

20 According to a preferred embodiment, the product obtained from the in-mouth stability test described above still exhibits an overrun of at least 100%, more preferably of at least 120%, and even more preferably at least 150%. Edible foam products that are capable of retaining a high overrun when subjected to conditions of shear that are similar to those observed during mastication and preferably that further exhibit high stability under gastric

25 conditions are extremely useful for the purposes of this invention. According to a

particularly preferred embodiment, the aforementioned criteria are also met by the foam products in the present composition, method and uses of the invention if the shear stability test is conducted at a temperature of 37°C, thus reflecting the prolonged in-mouth stability of the product under conditions of shear that are similar to those exerted during

30 mastication.

More preferably, the foam composition of the present invention, including in its uses and methods, has a physical (foam) stability such that the foam has a half life in the stomach of at least 20 minutes, preferably at least 30 minutes, more preferably of at least 45 35 minutes. "Foam half life in the stomach" herein is the gastric retention time where 50% of the foam volume ingested remains present as a foam in the stomach. The presence of a foam in the stomach, and thus the half life, can be determined by visualisation techniques as known in the medical profession. Of these, Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) scanning are preferred techniques, as they directly show the presence of foam, air and liquid. Ultrasound imaging can also be used for this, but due to differences in image quality and the interpretation of it a large enough set of test persons would be needed, as a person skilled in the art of ultrasound imaging would know. Also, with ultrasound imaging a foamed composition in the stomach as such cannot be visualised using ultrasound imaging, but the presence of foam can be derived from the reappearance of antral motility and ultrasound signal after the foam has left the stomach. Also, these imaging techniques can also be used to determine whether a foamed composition has a sufficient stability to pass the mouth and be present for some time as an aerated composition.

Even more preferably, the foamed compositions of the present invention, including in its uses and methods, have a very high gastric stability. Such high gastric stability of the foamed product can be apparent from the time (t ½ ) needed to achieve a reduction in overrun of 50% under simulated gastric conditions. The foamed product of the present invention exhibits a t ½ of more than 30 minutes. The aforementioned parameter t ½ is determined in a gastric stability test involving transferring 400 ml of an aerated edible product to a vessel of a United States Pharmacopeia (USP) dissolution model II apparatus (VanKel VK 7000), of which the temperature of the water bath is set to 37.5 °C and slow shear in the stomach is simulated with a special paddle at a stirring rate of 1.2 s "1

(72 rpm). Twenty five ml of fasted state gastric fluid, containing 80 μΜ sodium

taurocholate, 20 μΜ lecithin, 0.1 mg/ mL pepsin, 0.1 mg/ mL amano lipase A, 34.2 mM sodium chloride in water and set to pH 1.6 using hydrochloric acid, is subsequently carefully added along the vessel wall. A Masterflex® US pump is started simultaneously to pump simulated gastric fluid into the vessel at a rate of 0.8 ml/min. With the same rate, fluid from the bottom of the vessel is also removed. The foamed composition and the liquid volumes are read at start, after 5 min. and 10 min., and further at 10 min. intervals up to 60 minutes. The benefits of the foamed product in the present invention are particularly pronounced in case the gastric stability is very high. Accordingly, in a particularly preferred embodiment t ½ exceeds 45 minutes, even more preferably it exceeds 60 minutes, even more preferably it exceeds 90 minutes and most preferably t ½ exceeds 120 minutes. The compositions of the present invention and in the method and uses herein are such that they have an overrun of at least 100%. According to a preferred embodiment, the edible foamed product of the present invention has an overrun of at least 120%, more preferably of at least 150%, and even more preferably between 150% and 800%.

The gas phase in the present product can comprise air or any other gas that is considered safe for food applications.

The foam in the compositions, method and uses of the present invention is a pourable or spoonable aerated composition. According to one embodiment, the product is non- pourable (i.e. spoonable). Such a spoonable product typically exhibits spoonable rheology defined as follows: yield value of >50 Pa, when extrapolating from shear rates between 100 and 300 s "1 , a Bingham viscosity <500 mPa.s between shear rates of between 100 and 300 s "1 , a failure at stress at a strain of <0.5 Radians. The yield stress is determined at a temperature of 20 °C using a Haake VT550 viscometer. According to another embodiment, the edible foam product is pourable. A pourable product offers the advantage that it can be drunk. If the product is drunk rather than eaten, the chance of undesirable density increase as a result of mastication is minimised - for example bread is high overrun product, but practically all air is lost during mastication.

The foam in the compositions, methods and uses of the present invention is not a mousse and is not sponge-like. A mousse is herein to be understood as having a continuous phase that is a gelled phase, and this is to be distinguished from the currently used pourable and spoonable aerated compositions, in which the continuous phase of the aerated composition is not a gelled phase (but a liquid phase).

The foam in the compositions, methods and uses of the present invention is preferably non-frozen when ingested, as frozen compositions like ice cream tend to melt in the mouth and/or upper gastro-intestinal tract and following that lose their foam stability.

The foam in the compositions, methods and uses of the present invention preferably comprises by weight 50-99.5% water (more preferably 70-99%), a foaming agent and a stabiliser (next to caffeine and other physiologically active compounds, sweeteners, flavourings, colorants and other). ln this connection, the foaming agent preferably comprises, for a good foamed

composition, one or more of:

a food grade water-soluble emulsifier having an hydrophilic-lipophilic balance (HLB) value of at least 8, preferably at least 9, more preferably at least 12, - a food grade protein;

food grade amphiphatic particles having a contact angle at air/water interface between 70 and 120 degrees, and preferably having a volume weighted mean diameter of 0.02 to 10 micron (μηη). Examples of preferred food grade water-soluble emulsifier having an HLB value of at least 8, preferably at least 9, more preferably at least 12 herein are: sodium docecyl sulfate (SDS), SSL, polyoxyethylene 20 sorbitan monolaurate = polysorbate 20 (Tween 20), polysorbate 40 (Tween 40), polysorbate 60 (Tween 60), Bolec MT (enzymatically hydrolysed lecithin) and L1695 (lauric ester of sucrose, ex Mitsubishi-Kasei Food Corp.), and DATEM (diacetyl tartaric acid ester of monoglyceride).

Preferred food grade proteins in this connection comprise dairy proteins such as whey protein and/or casein protein and sources thereof, as well as vegetable proteins like soy protein, meat- and fish derived protein, and egg protein like albumin. When used as sole foaming agent, such food grade proteins are preferably used in an amount of from 1 to 7% by weight. Preferred food grade amphiphatic particles herein comprise one or more of cocoa particles.

As to the stabiliser, e.g. to give the product sufficient physical stability, e.g. to allow some time between preparation of the foamed composition, it is preferred that the stabilizer comprises a dietary fibre or a sucrose ester. Preferred amounts in this context are: from 0.1 to 5% by weight. Too little may not provide the desired stability, too much may make foaming difficult. Suitable dietary fibres in this context are one or more of the group consisting of: carrageenan, xanthan, cellulose, gellan, locust bean gum, with xanthan being the most preferred stabiliser (as it provides stabilising without too much viscosity increase).

Fat may be present in the compositions, methods and uses according to this invention, but such is preferably kept at a low level, so as not to induce too much calories to the composition. Also, fat may act detrimental on the stability of the aerated compositions. Hence, in the compositions in the methods and uses herein, the edible foamed composition comprises fat in an amount of less than 2% by weight, preferably less than 1.8% by weight, more preferably between 0 and 1.8% by weight, even more preferably between 0 and 1 .5% by weight, even more preferably form 0.01 to 1.5% by weight. Next to caffeine and other optional stimulants and the foaming agent, stabiliser, water and optionally fat, other components that may be present include carbohydrates, (non-caloric) sweeteners, flavouring components.

The edible foamed compositions of the present invention, and in the methods and uses of this invention as specified herein, can be prepared by any suitable means. The foamed compositions may be manufactured, packed and marketed in a foamed form, but it is also possible to prepare a non-aerated product which is packed and marketed, which is then foamed some time or immediately before consumption, either by the individual or at a point of sale or distribution. A convenient way (and one which can easily give foamed compositions of high stability) to offer such to users is when the composition according to this invention and for use in the method and uses of this invention is packed as a non- aerated (e.g. liquid) composition in a pressurised container in a liquid form. By this, the pressurised container can hold the edible liquid (non-aerated) composition and a propellant, which liquid composition can be released from the container by activating a valve (on the container) to produce an edible foamed product. Hence, more preferably, the invention further relates to the use in the composition, method and uses of the present invention of a pressurised container further comprising a propellant, and wherein the pressurised container is equipped with a valve, wherein the liquid can be released from the pressurised container by activating said valve to produce the aerated composition for the compositions, methods and uses according to this invention. Typically, the edible aerated product thus obtained has a density that is much lower (e.g. 40% lower) than that of the liquid composition in the container. According to a preferred embodiment, the edible foamed product produced upon activation of the valve has the same composition as the edible liquid composition (gas phase not being included).

Suitable propellants in this include compressed gases, especially liquefied gasses.

Preferably, the propellant employed is selected from N 2 0, N 2 , C0 2 , air and combinations thereof. Most preferably, the propellant employed is selected from N 2 0, N 2, C0 2 and combinations thereof. Typically, the propellant contained in the pressurised container has a pressure of at least 2 bar, more preferably at least 3 bar. Usually, said pressure does not exceed 12 bar. In a preferred embodiment, the pressurised container has a pressure of 2-15 bar, more preferably 2-12 bar.

Hence, in a further embodiment, the present invention relates to a pressurised container holding an edible liquid and a propellant, which liquid can be released from the container by activating a valve to produce an edible foam product, said edible foam product having an overrun of at least 50%, preferably at least 100%, wherein the edible liquid comprises water in an amount of from 50 to 99.5% (preferably 70-99%) by weight and caffeine in an amount of from 0.1 to 20 mg per g of edible liquid, more preferably the amount of caffeine in such is from 0.2 to 10 mg per g of edible liquid.

Following what was said previously in connection to other components possible, it may be preferred that the edible liquid in the pressurised container as set out herein further comprises taurine, in a weight ratio caffeine : taurine of from 1 : 5 to 1 : 40, more preferably from 1 : 8 to 1 : 25. Likewise, it may be preferred that the edible liquid in the pressurised container of the present invention further comprises glucuronolactone. When such is present, the amount of glucoronolactone is preferably such that caffeine and glucoronolactone are present in a weight ratio of from 1 : 2 to 1 : 25. Likewise, the edible liquid in the pressurised container according to the present invention may further comprise guarana. When guarana is present such is presentably in a weight ratio caffeine to guarana of from 1 : 5 to 1 : 100. Combinations of caffeine and two of the above stimulants in the ratios to caffeine given above are also hetin encompassed, and may be preferred for reasons of taste or effectiveness. For reasons as already specified for the foamed edible composition, the composition in the pressurised container preferably further comprises a foaming agent and a stabilizer. Preferred foaming agents and stabilizers have been set out herein before.

The pressurised containers according to the present invention may be of the re-usable type, e.g. as the iSi whipper, or may be of the single use version like foam dispensing containers as known from e.g. the personal care industry. Such may be used to dispense single or multiple portions. For reasons of convenience, preferably the container is of such size that the amount of liquid in the container is 10-500 ml, preferably 20 to 250 ml. Whether the foamed composition in the compositions, methods and uses as set out herein is packaged in a pressurised container or not, it is preferred in the present invention that th e foamed composition is prepared by the user from a composition which is packaged as a liquid. This liquid is then to be turned into the aerated composition before being consumed. Alternatively, the foam of the present invention may also be prepared by whipping a suitable liquid using, for instance, a standard kitchen mixer. By this, an amount of the liquid is added to the bowl of the mixer and mixed at high speed to aerate the

product. Typically, the edible aerated product thus obtained has a density that is much lower (e.g. 40% lower) than that of the liquid composition. Through varying the amount of liquid added to the bowl of the kitchen mixer and by varying the mixing time and speed, different levels of overrun can be achieved.

The gas bubbles contained within the edible foamed composition in the compositions, methods and uses according to this invention can vary widely in size. Typically, the air bubbles in the product have a volume weighted mean diameter in the range of 5-500 μηη, preferably of 10-200 μηη. The volume weighted mean diameter of the gas bubbles is suitably determined by means of optical microscopy.

The stability of the edible foamed product, especially if it is produced in situ from a pressurised aerosol system, is affected by the composition of the gas that is retained within the foamed product. In order to generate a very stable foamed product, it is advantageous to include a gas that has limited water-solubility. Air, for instance, is not particularly suitable as e.g. oxygen has a relatively high solubility in water. According to a particularly preferred embodiment, the edible foamed product in the present invention contains a gas that is less soluble in water than air (at a temperature of 37°C. According to another preferred embodiment, relative to air, the gas contained in foam product contains elevated levels of one or more of the following gasses: N 2 , N 2 0, C0 2 , He, 0 2 . Here the term "elevated" means that the concentration of at least one of said gasses is at least 10% higher than in air. EXAMPLES

Example 1

Edible foam product containing caffeine

Table 1. Composition of formulation for producing aerated edible products with caffeine.

A B

Ingredient % (w/w) % (w/w)

Skimmed milk powder 13.6 13.6

Xanthan gum 0.5 0.5

Orange syrup 0 10

Water 85.9 75.9

Caffeine 0.007 0

Paracetamol (=acetaminophen) 0 0.017

The liquid formulations can be prepared as follows. All ingredients are added to water and mixed until fully dispersed. Aeration can be done by weighing three hundred gram of formulation A in the metal bowl of a kitchen machine (Kenwood, model chef classic KM330). The liquid can be mixed at maximum speed for 1 min after which an overrun of 250% can be achieved.

Example 2

In vivo gastric stability of the aerated edible products.

Volunteers and study design

The study was a single-centre, randomized, placebo-controlled, balanced cross-over design consisting of a screening visit and three test days. The volunteers were recruited from local area of Nottingham. Selection criteria were: age 18-60 years, Body Mass Index (BMI, kg/m2) >20 and <35, apparently healthy (measured by questionnaire) and not using medicines judged likely to influence the study results. Only normal and low restraint eaters (Federoff et al, 2003; Polivy et al. 1978) were included. Any subjects with tendencies toward diagnosable eating disorders (anorexia nervosa or bulimia) were excluded

(Morgan et al., 1999). In total 20 subjects were screened to take part in the study of which 1 was not eligible and one withdrew after successful screening and before his first study day. From the eligible participants identified, 18 were randomised to take part in the study. Following the blind review of the study data, none of the subjects were withdrawn from the analysis, however, one subject only attended one test day due to a change in his diary commitments and data of another subject for one test day were not used for analysis as th is subject was not fasted at that day. Characteristics of the 18 subjects were:

age: 24.9 (range 19 - 38) y; BMI: 23.8 (range 20.3 - 29.5) kg/m2.

Volunteers were scanned on arrival at the centre to ensure their stomachs were empty (save resting gastric juices). Each day the subjects received one out of two isocaloric test products. An aerated beverage that was expected to be stable in the stomach ("Stable Aerated edible product") and an aerated beverage that was expected to be less stable in the stomach ("Less Stable Aerated edible product") (for details see in the other example provided herein).

Subjects were scanned at baseline to ensure their stomach was empty. They then consumed 150g of one of the products instead of breakfast and MRI measurements were conducted at several time points (up to 4 hours after consumption of the test product) to measure gastric behaviour. The subjects were blind to aerated test product type.

The participants were instructed to minimise changes in their physical activities and were not allowed to follow a diet one month prior to and during the test period. On the day before the test day the subjects were instructed not to use alcohol or play sports. They were asked to refrain from consuming any food or drink other than non-caloric beverages from 22.00 until arrival at the test facility. During the test day, the volunteers were instructed to avoid high intensity physical activity and direct contact with food. Volunteers were not allowed to eat and drink anything else during the study. Subjects were asked about their mode of transportation together with food consumption the evening before the test day and drinks consumed from 10 pm till the next morning. Test products

Two test products were evaluated:

1. 490 ml aerated drink comprising of 140 ml protein/carbohydrate beverage (13.6 wt% SMP, 0.5 wt% xanthan gum, 10 wt% lemon syrup, water) with an additional 350 ml of air (= total volume 490 ml, "Stable Aerated edible product")

2. 490 ml aerated drink comprising of 140 ml protein/carbohydrate beverage (13.6 wt% SMP, 0.1 wt% xanthan gum, 10 wt% lemon syrup, water) with an additional 350 ml of air (= total volume 490 ml, "Less Stable Aerated edible product") The test products were equicaloric (1 10kcal) and their nutritional composition is detailed in Table 2. Table 2. Nutritional composition of test products

volume weight Energy 3 Fat Protein Carbohydrate

of which of which

Total b sugars fibres

[ml] [g] [kcal] [g] [g] [g] [g] [g]

Stable 490 150 1 10 0.2 7.2 20.2 18.6 0.8 c

Aerated

edible product

Less Stable 490 150 108 0.2 7.2 19.6 18.6 0.2 d

Aerated

edible product

Key: a based on energy content of fibres of 4 kcal/g

b total carbohydrates, including sugars and fibres c contains 0.8 g xanthan gum

d contains 0.2 g xanthan gum

Both aerated edible products were produced by aerating the beverage with air.

All test products' overrun was measured and amounted 247% ± 7% for the stable and 254% ± 3% less stable aerated edible products. For both test products, the simulated oral cavity test as described in example 6 reduced the overrun of the aerated edible products by less than 5%.

Magnetic resonance imaging (MRI)

All MRI was carried out on a 1.5 T Philips Achieva MRI research-dedicated scanner (Philips Healthcare) sited at the University Campus, Nottingham using a parallel imaging receiver coil wrapped around the abdomen. The BTFE, single shot MRI sequence used acquired 30 contiguous slices across the abdomen under a 12 seconds expiration breath- hold. The final, optimised sequence parameters were: 80° flip angle, TR=2.8 ms, TE=1 .40 ms, acquired resolution of 2.00 mm x 1.77 mm x 10 mm (reconstructed to 1.56 mm x 1.57 mm x 10 mm). This was run in the transverse (axial) plane. For the coronal ('frontal view') single shot, fast spin echo sequence (as used in MRCP) the sequence parameters were: multi-slice 2D single shot imaging, TEeff = 320 ms, TReff =∞, 24 slices, SL = 7 mm, FOV = 400 mm, RFOV = 90%, scan percentage = 80%, acquired voxel size=1 .56 x 2.83 x 7mm3 (interpolated to 0.78 χ 0.78 * 7mm3), total scan time = 24 s acquired in a single breath-hold. The subjects were supine on the scanner bed. They were kept tilted with their left side slightly raised on the scanner bed using a folded towel to help avoiding the possibility that floating layers of the test meals could empty first through the pylorus, which would be different from what happens during normal upright digestion.

The validity of MRI measurements of gastric volumes (from single scans) and of gastric emptying has been validated against intra gastric balloon infusion (Boulby et al., 1997) and against double marker indicator (Schwizer et al., 1994) and gamma scintigraphy (Feinle et al., 1999).

Gastric aerated edible product volume was measured from the balanced gradient echo (also called balanced turbo field echo or BTFE). At each time point 30 axial, 2D slices of the abdomen were acquired. Every data set from each time point was then recalled on a UNIX workstation for analysis. On such axial sections, commercial specialistic software (Analyze 9, Biomedical Imaging Resources, Mayo Clinic, Rochester, MN) was used to trace manually on each 2D slice around the region of interest (ROI) of the aerated edible product in the stomach on each slice. These series of 2D ROIs were then collected together as a 3D total volume and saved as a text file for input into an Excel database. Statistical analysis

Analyses were carried out using both ITT (Intention To Treat) and PP (Per Protocol) populations. Analysis for ITT and PP had similar results and conclusions. Therefore only the ITT results are reported here. Results

Gastric aerated edible product volume

There was good contrast in the MRI images for all 2 products, with the three regions of air, aerated edible product and liquid clearly defined (Figure 2). On the T2 weighted BTFE images acquired in this study, liquids appear bright white. The aerated edible products appeared naturally darker than fluid and than other organs like the spleen, due to the aerated edible product's lower water proton density and air bubble matrix affecting the signal itself. As such, the images' intensity display scale was increased for better visualisation of the aerated edible products, for display, and for analysis.

All three phases could clearly be distinguished on the images and measured and the regions of interest (ROIs) were converted to volumes. Figure 2 shows examples of ROIs drawn intragastrically for a Stable Aerated edible product and a Less Stable Aerated edible product at different time points. These were plotted in Microsoft Excel to allow for observations on the time courses of intragastric volumes.

The intragastric aerated edible product volumes mean time series are shown in table 3. At t=10 min after intake the volume of aerated edible product for the Stable Aerated edible product test product was significantly higher than for the Less Stable Aerated edible product test product. After that postprandial time point and at all time points up to T=90 min the mean intragastric aerated edible product volumes for the Stable Aerated edible product were also higher than those for the Less Stable Aerated edible product. The most significant differences were found within the first 70 min after treatment intake.

Conclusions

The study showed that MRI is very appropriate to measure serially separate volumes of aerated edible product after ingestion of aerated products. The decrease in aerated edible product volume was clearly slower for the Stable Aerated edible product as compared to the Less Stable Aerated edible product.

Table 3 Stomach aerated edible product content (LSmeans, in ml) in time for the different treatments (less stable aerated edible product, stable aerated edible product).

Treatment

Less Stable Aerated edible product Stable Aerated edible product

Time Volume Standard Volume Standard

(ml) Error Lower Upper (ml) Error Lower Upper

-15 0.0 0.0

10 373.3 14.2 344.6 402.1 444.4 13.7 416.6 472.2

30 102.3 16.4 69.2 135.3 309.8 15.8 277.8 341 .7

50 25.8 13.1 -0.6 52.2 160.9 12.6 135.4 186.4

70 9.5 9.8 -10.4 29.3 63.1 9.5 43.9 82.3

90 3.5 3.2 -3.1 10.0 12.1 3.1 5.8 18.4

120 0.3 0.5 -0.7 1 .3 1 .2 0.5 0.2 2.1

150 0.1 0.1 -0.2 0.4 0.3 0.1 -0.0 0.5

180 -0.0 0.1 -0.1 0.1 0.1 0.1 -0.0 0.2 Example 3

Correlation in vitro and in vivo gastric stability of the aerated edible product.

Formulation B from example 1 was aerated by weighing four hundred gram of formulation B in the metal bowl of a kitchen machine (Kenwood, model chef classic KM330). The liquid was mixed at maximum speed for 1 min after which an overrun of 250% was achieved.

In mouth stability of aerated edible products containing paracetamol

The aerated composition was put into a glass funnel (diameter 100 mm, neck length 100 mm and a neck diameter of 10 mm). The funnel was connected to a silicone tube with a length of 400 mm and a diameter of 12x8 mm. The middle part of the silicone tube was inserted into a peristaltic pump (Watson-Marlow model 501 ) and operating at 60 rpm. Aerated edible product pumped through the silicone tube was collected in a previously weighed vessel. The impact of the simulated oral cavity test is determined by observing the start (400 mL) and end volume. The simulated oral cavity test reduced the overrun of the aerated edible product by less than 5%.

This example shows an edible foam of sufficient oral stability.

In vitro gastric stability of aerated edible products

After collecting aerated edible product from this mouth stability test, 400 ml was transferred to a vessel of the USP dissolution model II apparatus. The temperature of the water bath was set to 37.5 °C. The slow shear in the stomach was simulated with a special paddle at a stirring rate of 1 .2 s "1 (72 rpm). The vessel was weighed and placed in the USP model and the stirring was started. Twenty five ml of fasted state gastric fluid (Table 4) was pipetted carefully along the vessel wall. A Masterflex® US pump was started simultaneously to pump simulated gastric fluid into the vessel at a rate of 0.8 ml/minute. With the same rate fluid from the bottom of the vessel was also removed. The aerated edible product and the liquid volumes were read at start (t = 0, after 5 min. and 10 min., and further at 10 min. intervals up to 60 minutes. Table 4. Composition of fasted state gastric fluid, pH=1.6

Ingredient Amount per 500 ml

Sodium taurocholate (80 μΜ) 21 .52 mg

Lecithin (20 μΜ) 7.6 mg

Pepsin ( 0.1 mg / mL ) 50 mg

Amano lipase A 50 mg

Sodium chloride ( 34.2 mM) 1 gram

Hydrochloric acid to set pH to 1.6

Deionized water Fill up to 500 ml

Figure 1 shows the stability of the aerated edible product under simulated gastric conditions. Less than 40% of aerated edible product is digested within 60 min under the conditions used in this test. The t ½ is 55 minutes.

This example shows a paracetamol-containing foam of good in-vivo gastric stability.

Also the study products used in the MRI study (example 2) were tested for in vitro gastric stability using this same method. The overrun of the aerated edible products was 250%. The run time of the gastric step was 50 minutes. The results are given in figure 3. Figure 4 shows the linear regression between the data points from the MRI study and the in-vitro gastric stability test. The results clearly show that the in vitro model for gastric stability correlates well with the in vivo gastric stability of aerated edible products. Example 4

Dose dependency of aerated edible products on satiety.

Study design

The study used a random allocation, parallel design, with treatments balanced across test days. Each subject group was given a single exposure to a single volume of an aerated edible product, each portion having a volume of 10, 25, 50, 100, 150 or 250 ml. This product was given as a mid-morning snack (at 10.30 am) following a fixed 250 kcal breakfast given at 08.00 am. Self-reported eating motivation ratings (6 scales) were collected regularly from 155 minutes prior to consumption of the test product and for 3 hours afterwards.

Subjects

Healthy normal weight and overweight male and female participants (age 18-50 yr, BMI 20-32 kg/m 2 ) were recruited from local area of the research centre. Only normal and low- restraint eaters were included, based on the Revised Restraint Scale (Polivy et al., 1978; Federoff et al., 2003). Any subject with a tendency toward a diagnosable eating disorder (anorexia nervosa or bulimia) was also excluded based on the SCOFF questionnaire (Morgan et al., 1999). From the eligible participants identified, 144 were admitted onto the study. Potential volunteers were trained on completion of visual analogue scales (VAS) for subjective ratings of ingestive behaviour, and were familiarized with the test product and the study design.

The 144 participating subjects were randomized into groups of 24 subjects per treatment, with groups matched for gender mix, age and body weight (mean within 5 yr and 5 kg). Ten subjects were withdrawn from the study for reasons unrelated to the study products. Characteristics of the remaining 133 subjects (91 females, 42 males) were: age: 35.8 (range 18 - 60) y; BMI: 24.8 (range 21.0 - 34.6) kg/m 2 .

Study products

Each subject was given a single exposure to a single portion of an aerated edible product at a specified volume at 10.30 following a fixed breakfast at 08.00. Six aerated edible products were evaluated varying in total volume.

The test products consisted of Slim-Fast Optima high protein ready-to-drink meal replacement shakes (190 kcal/325 ml when not aerated), aerated on site with N 2 0 (from an iSi dispenser and using an iSi N 2 0 disposable gas filled cylinder) (Slim-Fast is a trademark of Unilever PLC, United Kingdom and Unilever NV, Netherlands; iSi is a tradename of iSi GmbH). An ingredients list of the non-aerated SlinvFast high protein chocolate RTD shake base is shown in Table 5. The liquid formulation used was the same as the commercial product identified above, but with a different chocolate flavouring component. The overrun of the product was approximately 200%. This means that the energy content per serving was approximately 2, 5, 10, 19, 29 and 48 kcal for the 10, 25, 50, 100, 150 and 250 ml aerated servings (corresponding to approx. weights of 4, 1 1 , 18, 35, 50 and 85 gram servings), respectively. Table 5. Nutrient composition of Slim -Fast High Protein Extra Creamy Chocolate RTD shake (US formulation)

Amounts per can (325 ml)

Calories 190

Total Fat 5g

Saturated Fat 2g

Cholesterol 10mg

Sodium 220mg

Potassium 600mg

Total Carbohydrate 24g

Dietary Fiber 5g

Sugars 13g

Protein 15g

+ Vitamin-Mineral complex

Ingredients: Fat Free Milk, Water, Calcium Caseinate, Milk Protein Concentrate,

Maltodextrin, Cocoa (Processed with Alkali), Canola Oil, Gum Arabic, Cellulose Gel, Sugar, Mono and Diglycerides, Fructose, Potassium Phosphate, Soybean Lecithin, Cellulose Gum, Carrageenan, Artificial Flavor, Isolated Soy Protein, Sucralose and Acesulfame Potassium (Non Nutritive Sweeteners), Dextrose, Potassium Carrageenan, Citric Acid and Sodium Citrate. Vitamins and Minerals: Magnesium Phosphate, Calcium Phosphate, Sodium Ascorbate, Vitamin E Acetate, Zinc Gluconate, Ferric

Orthophosphate, Niacinamide, Calcium Pantothenate, Manganese Sulfate, Vitamin A Palmitate, Pyridoxine Hydrochloride, Riboflavin, Thiamin Mononitrate, Folic Acid, Chromium Chloride, Biotin, Sodium Molybdate, Potassium Iodide, Phylloquinone (Vitamin K1 ), Sodium Selenite, Cyanocobalamin (Vitamin B12) and Cholecalciferol (Vitamin D3).

At least 24 hours before the test day the SlinvFast high protein chocolate RTD was stored at 5 °C, while the iSi N 2 0 gas filled cylinder and dispensers were stored at room temperature. All test products were presented in an accompanying beaker. All aerated edible products were consumed with a 10 ml black plastic spoon and the subjects were instructed to eat all of the aerated edible product within 10 minutes. All test products were prepared on the test days, according to a standard operating procedure. In short, the content of one 325ml can of Slim-Fast high protein chocolate shake was poured into the stainless steel iSi bottle and the device head was screwed onto the stainless steel bottle One iSi N 2 0 gas filled cylinder was inserted into the cylinder holder and the cylinder holder was screwed to the device head until all of the content of the cylinder was released into the bottle. Thereafter the device was vigorously shaken for 20 seconds. The foam was then dispensed by turning the device upside down with the decorator tip in the vertical position and gently pressing the lever. The entire amount (~900ml) was dispensed 5 against the inside edge of a large glass container and then the required foam volumes was poured into glasses which had been pre-marked with the required volume. The weight of the foam was subsequently measured.

Subjective feelings of hunger and satiety

10 Self-report ratings for appetite measures were collected at time points of -155, -120, -90, - 60, -30, -5, 15, 30, 60, 90, 120, 150, and 180 min (where test product consumption at 1030 was regarded as 0 min). Ratings of satiety feelings were scored using reproducible and valid scales (Stubbs et al., 2000; Flint et al. 2000) by means of a mark on 60-mm scales using EVAS (Electronic Visual Analogue Scale, iPAQ; Stratton et al. 1998) (iPAQ is

15 a trademark of Hewlett Packard, USA) anchored at the low end with the most negative or lowest intensity feelings (e.g., not at all), and with opposing terms at the high end (e.g., very high). Volunteers were asked to indicate on a line which place on the scale best reflects their feelings at that moment. The scale items were "desire to eat a meal", "desire to eat a snack", "hunger", "how much do you want to eat", "satiety" and "fullness".

20

Analyses

The study was a product benchmarking study, aimed to generate a dose-response profile for satiety effects, focused on identifying lower volume limits for potential consumer concepts. Curves of Least Square means (LSmeans) were produced based on the 25 measurements, and based on these curves a time-to-return-to-baseline (TTRTB) was calculated by using a modeling technique based on the Weibull distribution (Schuring et al 2012). This Weibull method also turned out to be the most suitable, non-parametric model to estimate TTRTB for these satiety curves.

30 Results

The consumption of small portions of aerated edible product in between meals (i.e. as a snack) induced clear effects on eating motivational ratings. The results indicate a rough dose-response, although this is not completely consistent across the different line scales used. Strongest, robust effects are shown for 250 ml, while no effect is observed for the 35 10 or 25 ml (see Tables 6, 7 and 8). For 10 and 25 ml the TTRTB estimates could not be calculated, as the curves did not cross the baseline. This is consistent for all line scales. Intermediate effects of aerated edible product on feelings of hunger and satiety were observed for the 50, 100 and 150 ml. For all line scales the 50, 100 and 150 ml volumes showed greater responses as compared to the 10 and 25 ml. Table 6. Time to return to baseline (TTRTB) for 'Desire to eat a meal'

1 TTRTB (minutes) by Weibull modeling

Table 7. Time to return to baseline (TTRTB) for 'Desire to eat a snack'

1 TTRTB (minutes) by Weibull modeling

Table 8. Time to return to baseline (TTRTB) for 'Hunger'

1 TTRTB (minutes) by Weibull modeling

Conclusion

A previous study has shown that aeration of liquid meal replacements leads to a high magnitude and duration of hunger suppression (increased satiety), which is substantially greater than non-aerated control products (De Groot et al., 2008; Blijdenstein et al., 2008) and also greater than examples in literature (e.g., Rolls et al., 2000; Osterholt et al., 2007). In that study the foam was consumed as a breakfast. It was, however, unknown, at what minimum volume a meaningful effect on satiety could still be observed. A quick estimate of response profiles to 6 foam volumes (10-250 ml) was therefore established. The results indicate a rough dose-response. Strongest, robust effects are shown for 250 ml, while no effect is observed for the 10 or 25 ml. This was consistent for all line scales. Surprisingly, effects were also observed for the 50, 100 and 150 ml where intermediate effects were seen. In 4 out of 6 line scales the effect of 150 ml on peak and duration is somewhat more pronounced than the 50 and 100 ml, but for all line scales the 50, 100 and 150 ml volumes showed greater (and longer) responses as compared to the 10 and 25 ml.

The 50 ml and 100 ml contained only 10 and 19 kcal per serving respectively, yet showed meaningful effects on appetite. The effects on appetite observed here are greater (and persist for longer) than shown in literature for beverages having either no caloric content or a caloric content which is higher than the foams now tested, at the same volume. Peters et al. (201 1 ) for instance tested a 100 ml minidrink as a snack and effects on hunger and appetite were comparable or even smaller compared to the effects seen here for the 50 or 100 ml foam, yet the 100 ml minidrink contained considerably more energy (80 kcal). Comparable or even smaller effects on appetite were also seen when testing 150 ml soup containing 150 kcal (Gray et al 2002) or 300 ml dairy-based drink containing 500 kcal (Rolls et al 2000). Although plain water or artificially sweetened water do decrease appetite, volumes needed are much higher and the temporal effect is much shorter as compared to the 50 or 100 ml foam (e.g. Monsivais et al., 2007)

The 250 ml volume led to an appetite response with an estimated TTRTB of 96 to 180 minutes, depending on the appetite rating used. Also the 100 and 150 ml volume produced a meaningful increase in TTRTB, generally between 45 and 93 min, depending on the appetite rating used. The 50 ml also generated a meaningful increase in TTRTB varying from 41 to 89 minutes, depending on the appetite rating used. For the 25 and 10 ml these values could not be estimated, as the curves did not cross the baseline (in the majority of subjects). TTRTB/kcal for hunger: 79/10, 80/19, 66/29 and 120/48 = 7.9, 4.2, 2.3 and 2.5 min/kcal for the 50, 100, 150 and 250 ml servings.

TTRTB/kcal for desire to eat a meal: 41/10, 45/19, 69/29 and 96/48 = 4.1 , 2.4, 2.4 and 2.0 min/kcal for the 50, 100, 150 and 250 ml servings.

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Description of the figures

Figure 1. Stability of an aerated edible product (example 3) under simulated gastric conditions. Results are means ± standard deviation of 3 experiments.

Figure 2. Comparison of the behaviour of the aerated edible products in the stomach. The intensity scales are increased for better visualisation of the aerated edible product, a) Stable Aerated edible product at time 10 minutes,

b) Stable Aerated edible product at time 50 minutes.

These images are from the same volunteer on the same study day.

c) Less Stable Aerated edible product at time 10 minutes,

d) Less Stable Aerated edible product at time 50 minutes.

Figure 3. Correlation between gastric emptying (expressed in volume) from the MRI study data and the in-vitro test.

Legend:

♦ in-vitro stable foam

♦ in-vitro less stable foam

■ study less stable foam

▲ study stable foam

Figure 4. Linear regression between gastric emptying (expressed in volume) from the MRI study data and the in-vitro test.

Legend:

♦ less stable foam

▲ stable foam