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Title:
POLYPHENOL AND PROBIOTIC CONTAINING NUTRITIONAL SUPPLEMENT
Document Type and Number:
WIPO Patent Application WO/2007/009187
Kind Code:
A1
Abstract:
A food additive composition including a polyphenol , such as a polyphenol containing product derived from grape seed, apple, pear, green tea or cocoa extracts, in combination with a probiotic, such as a probiotic selected from lactobacilli and bifidobacteria species. A food product or daily food incorporating this food additive. A method of improving cardiovascular health in a subject by administering the food additive composition to the subject.

Inventors:
KEITH, Suzanne (Samuel Road, Nuriootpa, South Australia 5355, AU)
Application Number:
AU2006/001028
Publication Date:
January 25, 2007
Filing Date:
July 20, 2006
Export Citation:
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Assignee:
TARAC TECHNOLOGIES PTY LTD (Samuel Road, Nuriootpa, South Australia 5355, AU)
KEITH, Suzanne (Samuel Road, Nuriootpa, South Australia 5355, AU)
International Classes:
A61K35/74; A23C9/13; A23C13/16; A23C17/02; A23C21/08; A23L1/30; A61K31/353; A61K36/87; A61P9/14; A61P39/06; A61K131/00
Domestic Patent References:
2004-10-14
2002-08-15
2006-05-11
Foreign References:
EP1600061A12005-11-30
EP1020123A12000-07-19
US20040001817A12004-01-01
US20050118694A12005-06-02
EP0904784A11999-03-31
Other References:
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DATABASE WPI Week 200404, Derwent Publications Ltd., London, GB; Class D13, AN 2004-039509, XP003007501 & JP 2003 339353 A (TOYO SHINYAKU KK) 02 December 2003
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DATABASE WPI Week 200622, Derwent Publications Ltd., London, GB; Class D13, AN 2006-213055 & WO 2006 028164 A1 (KIRIN BEER KK) 16 March 2006
DATABASE WPI Week 200302, Derwent Publications Ltd., London, GB; Class B04, AN 2003-029992 & WO 02 080946 A1 (WAKAMOTO PHARM CO LTD) 17 October 2002
DATABASE WPI Week 200370, Derwent Publications Ltd., London, GB; Class B04, AN 2003-735677 & JP 2003 113105 A (ARIAKENORI KK) 18 April 2003
Attorney, Agent or Firm:
LESICAR PERRIN (49 Wright Street, Adelaide, SA 5000, AU)
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Claims:

Claims

1. A food additive composition including a polyphenol in combination with a probiotic.

2. A food additive according to claim 1 wherein that the probiotic is selected from lactobacilli and bifidobacteria species.

3. A food additive according to claim 3 in which the probiotic is selected from L casei, B lactis, L johnsonii, B breve, L bulgaricus, B animalis, L rhamnosus, B infantis, L reuteri, B longum, and L acidophilus.

4. A food additive according to any of the preceding claims, wherein, the polyphenol product is derived from natural sources.

5. A food additive according to any of the preceding claims, the polyphenol product is derived from any combination of grape seed, apple, pear, green tea or cocoa extracts.

6. A food additive according to any of the preceding claims, wherein the polyphenol product is a proanthocyanidin rich product.

7. A food additive according to any of the preceding claims, further including vitamin and/or mineral supplements.

8. A food additive according to any of the preceding claims, wherein the additive is supplied in tablet, capsule or freeze dried powder form

9. A food additive according to any of the preceding claims, wherein the additive is supplied in combination with a food product.

10. A food additive according to claim 9, wherein the additive is incorporated into a dairy food.

11. A food additive according to claim 10, wherein the food product is a yoghurt product or a milk or other dairy product including cream, buttermilk, powdered milk, and frozen desserts.

12. A food additive according to any once of the preceding claims in which the composition 0.5-2.5g of polyphenol product.

13. A method of improving cardiovascular health in a subject in need thereof, the method consisting of administering to the subject a composition according to any one of claims 1-11.

14. A method according to claim 12 wherein the composition is administered on a regular basis.

15. A method according to claim 12 wherein the composition is administered on a daily basis.

Description:

POLYPHENOL AND PROBIOTIC CONTAINING NUTRITIONAL

SUPPLEMENT

FIELD OF THE INVENTION

The present invention relates to a food or nutritional supplement composition

BACKGROUND OF THE INVENTION

Biologically active polyphenols are powerful antioxidants. It is known that there are overall health benefits from antioxidant-rich foods consumed in the diet. Antioxidants have been associated with a wide range of health benefits including their ability to scavenge free radicals, maintain healthy vision and, perhaps most importantly their ability to improve cardiovascular health, as well as suggested ability to reduce the risk of cancer and improve immune function.

To this end health professionals frequently recommend the inclusion of polyphenol rich foods, including fresh fruit and vegetable as a part of a healthy diet. Red wines, chocolate and green tea are also noted sources of polyphenols. Many individuals concerned for their health also choose to supplement their diet to take account of any dietary inadequacies or to improve health in general. Supplements have been developed that are rich in antioxidant polyphenols. Grape seed extract, in particular, has been marketed in a variety of guises as a product having antioxidant properties.

However, notwithstanding the apparent commercial success of various antioxidant food additive and nutritional products, it is has proved difficult to demonstrate convincingly the ability of antioxidant supplement products to confer the health benefits ascribed to antioxidant products. It is also becoming clear that currently available additive products are not as effective as perhaps they might be.

The present invention is addressed to this situation and provides an alternative additive composition to those currently available.

It is known that polyphenols are poorly absorbed in the gut. For example, catechin and epicatechin, the major phenol monomers in red wine, are well absorbed while the polymers of catechin and epicatechin (proanthocyanidins or tannins) are not absorbed

intact to any degree. Thus, current food supplements, such as grape seed extracts, which are concentrated sources of polyphenols are poorly absorbed.

It has also been suggested that proanthocyanidin polymers, which cannot be absorbed through the wall of the small intestine because of their high molecular weight, are open to degradation by colonic microflora into lower molecular weight metabolites. The inventors of the present invention propose that the beneficial health effects to be obtained from polyphenol products may be enhanced by increasing the bioavailability of the active substances obtained from metabolism of polyphenols.

It is an object of the present invention to provide a composition that enhances the ability of gut microflora to metabolise polyphenols and to enhance the bioavailability of active metabolic products resulting from such metabolism

SUMMARY OF THE INVENTION

Therefore according to a first aspect of the present invention there is provided a food additive composition including a polyphenol in combination with a probiotic.

Probiotics are an important part of the complex world of foods that are good for health. Probiotics are foods that contain live bacteria. It is the bacteria and metabolites which they produce that give these probiotics their health promoting properties.

The health of the gut largely relies on the balance between good and bad bacteria, and probiotics may help the gut prevent an imbalance in which there are too many harmful bacteria. Research on probiotics has shown that probiotics may be promising as treatments for a number of diseases and conditions, including lactose intolerance, diarrhea secondary to antibiotic use or E coli infections, other gastrointestinal infections, vaginal candidiasis infections, and lactose malabsorption due to chemotherapy. Research has reasonably well established that probiotics improve the body's ability to resist intestinal infection.

The two most common bacterial species added in the production of probiotic foods are lactobacilli and bifidobacteria. There are numerous strains of lactobacilli and bifidobacteria; the main strains thought to have probiotic characteristics are L casei, B

lactis, Ljohnsonii, B breve, L bulgaricus, B animalis, L rhamnosus, B infantis, L reuteri, B Iongum, and L acidophilus.

However, it has not before been suggested that probiotic products may be usefully combined with polyphenol products to provide a food additive. Indeed the finding of the inventors may be considered surprising. The role of probiotic products in promoting gut health has often been related to ability of the probiotic to reinforce the intestinal mucosal barrier against deleterious agents, and to reduce the permeability of the gut wall to pathological agents, large molecules and bacteria. Probiotic products are considered to have little or no effect on the main physiological functions of the gut including absorption. It is thus surprising to suggest that a combination of a polyphenol and a probiotic would produce a beneficial effect.

The composition of the invention has been demonstrated to positively influence indicators of cardiovascular health. Thus, according to a further aspect of the present invention there is provided a method of improving cardiovascular health in a subject in need thereof, the method consisting of administering to the subject a composition including a probiotic in combination with a polyphenol.

Preferably, the polyphenol product is derived from natural sources.

Preferably, the polyphenol product is derived from grape seed, apple and pear, green tea or cocoa extracts.

More preferably, still the polyphenol product is a proanthocyanidin rich product.

Preferably, the composition of the invention is administered on a regular basis, most preferably on a daily basis.

Preferably a single dose of a composition in accordance with the invention contains from 0.5-2.5g of polyphenol product in combination with a probiotic component.

Grape seed extract (GSE) is a complex mixture of proanthocyanidin monomers (primarily catechin and epicatechin), dimers, trimers and larger species. According to the proposal of the invention, gut bacteria metabolise the polymers present in the

GSE 1 assisted by the presence of the probiotic. The effect of the composition on vascular health compares favourably to any effect resulting from administration of either the polyphenol product alone or the probiotic alone.

It should be noted that the composition of the invention is not proposed as a mere admixture having the known health benefits of the components of the composition, but rather it is proposed that the composition exhibits effects beyond that which would be expected from the known properties of the various components. A hitherto unsuspected interaction between the components and the subject is thus proposed.

The best known example of a probiotic product is yogurt, although probiotic products may also be found in sour cream, buttermilk, powdered milk, and frozen desserts. Probiotics may also be supplied as supplements in tablet, capsule, and freeze-dried preparations.

Thus, the composition of the invention may be supplied in the form of a food product incorporating the components of the composition. Thus, for example, the composition of the invention may be incorporated into a dairy food, for example, yoghurt product or a milk or other dairy product. Alternatively, the composition of the invention may be supplied in other food products. Alternatively, the composition of the invention may be supplied in tablet, capsule or powder form, either alone or additionally incorporating other desirable products, for example vitamin and mineral supplements.

DESCRIPTION OF DRAWINGS

The above and other objects, features, and advantages of the present invention will be apparent from the following detailed description of a preferred embodiment in conjunction with the accompanying drawings. In the drawings:

Figure 1 illustrates flow mediated dilation responses to consumption of grape seed extract in cordial against a control;

Figure 2 illustrates flow mediated dilation responses to consumption of grape seed extract in yoghurt containing probiotics against a control;

Figure 3 illustrates flow mediated dilation responses to consumption of grape seed extract in milk against a control; and

Figure 4 represents phenolic acids measured in urine samples following ingestion of foods containing polyphenols in the form of grape seed extract.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The following detailed description of the invention refers to an exemplary composition of the invention. Although the description refers to such exemplary embodiments, other embodiments are possible, and changes may be made to the embodiments described without departing from the spirit and scope of the invention.

The effects of administration of a composition formulated in accordance with the invention may be demonstrated with reference to its effect on the vascular phenomenon measured by flow mediated dilation (FMD). FMD is one of the most sensitive indicators of vascular health. FMD is a nitric oxide mediated process.

The effect of a polyphenol product alone, in various foodstuffs, or together with a probiotic product, in the form of a probiotic (L acidophilus and bifidus) containing yoghurt were measured.

2g of GSE were administered in different food matrices (yoghurt, milk) and in cordial to 4 subjects and subsequent measurements of flow mediated dilation taken. After a 3-day low polyphenol period, these individuals randomly took 2g of GSE in the food or cordial in the fasting state and had blood samples taken and flow mediated dilatation (FMD) assessed at 0 (fasting), 1 , 2, 4, 8 and 24 hours. Subjects continued to fast until 4 hours after the consumption of the test foods and followed the low-polyphenol diet until the intervention period was completed. Subjects also completed control days in which the same food or cordial was taken without GSE and exactly the same protocol was followed (i.e. each subject had a total of 48 blood samples and ultrasounds on 8 separate days). Each testing phase was separated by a minimum of a 1 week washout period. Urine was collected for measurement of phenolic acids over 5 12 hour time periods: free living, after a 3 day low polyphenol period, 0-12 hours after GSE (or control) ingestion, 12-24, 24-36, 36-48 hours. Plasma catechin and epicatechin were also measured at each time point.

FMD values obtained over time for the different foods are shown in figures 1- 3. Figure 1 illustrates graphically the results obtained from the incorporation of GSE

alone in cordial. In this context cordial serves as a neutral food medium. It can be seen that the GSE mediates the post prandial drop observed in FMD.

The food matrix appeared to influence the FMD responses with the blunting of FMD drop being most evident when GSE was consumed in yoghurt, that is when a combination of polyphenols and probiotics were consumed. Importantly, the combination provided significant improvements where compared with ingestion of polyphenol without an accompanying probiotic component.

Comparing FMD values in milk and yoghurt (figures 2 and 3) it was observed that the FMD profile was similar for milk with and without GSE, indicating a relatively modest effect for the GSE in this case. However, the presence of a combination of GSE and probiotics, as could be found in the yoghurt sample shown in Figure 2, had a far more pronounced effect on early fall in FMD observed after consumption of the yoghurt. Thus, these results indicate enhanced FMD and by inference, improved vascular health, following consumption of the polyphenol probiotic composition according to the invention.

Further support for this view can be obtained by considering the results of urine analysis as shown in figure 4. In general, the presence of phenolic acids in urine is a good indicator of metabolism of dietary polyphenols. The combination of polyphenol with probiotic in the GSE yoghurt combination clearly provided the highest level of urinary phenolics. The existence of the metabolites of GSE in the urine indicates that the grape seed extract has been consumed and metabolized.

Further advantages and improvements may very well be made to the present invention without deviating from its scope. Although the invention has been shown and described in what is conceived to be the most practical and preferred embodiment, it is recognized that departures may be made therefrom within the scope and spirit of the invention, which is not to be limited to the details disclosed herein but is to be accorded the full scope of the claims so as to embrace any and all equivalent devices and apparatus.

In any claims that follow and in the summary of the invention, except where the context requires otherwise due to express language or necessary implication, the

word "comprising" is used in the sense of "including", i.e. the features specified may be associated with further features in various embodiments of the invention.