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Title:
FOOD PRODUCT OR A SEASONING THEREOF CONTAINING BENTONITE OR MONTMORILLONITE HAVING ACTIVITY OF METABOLIC PROTEIN LOAD REDUCTION
Document Type and Number:
WIPO Patent Application WO/2014/037877
Kind Code:
A1
Abstract:
A food product or a seasoning for food product for the reduction of protein load in a subject, characterized in that it comprises bentonite or montmorillonite, is disclosed. Said subject is selected from the group consisting of: a subject affected by diabetes, a subject affected by chronic renal failure, a subject affected by metabolic diseases, in particular urea cycle defect, and a subject undergoing a hyperproteic diet, for example an athlete.

Inventors:
MICHIELAN, Paride (via Udine, 130, Porpetto, I-33050, IT)
NOT, Tarcisio (via Commerciale 19, Trieste, I-34132, IT)
Application Number:
IB2013/058255
Publication Date:
March 13, 2014
Filing Date:
September 03, 2013
Export Citation:
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Assignee:
IRCCS MATERNO-INFANTILE BURLO GAROFOLO - OSPEDALE DI ALTA SPECIALIZZAZIONE E DI RILIEVO NAZIONALE PER LA SALUTE DELLA DONNA E DEL BAMBINO (Via Dell'Istria, 65/1, Trieste, I-34137, IT)
EASY & GOOD S.R.L. (Via Marconi 6, San Daniele del Friuli, I-33038, IT)
International Classes:
A23L1/308; A21D2/02; A23L1/00; A23L1/015; A23L1/304; A23L2/52; A61K33/06
Domestic Patent References:
WO2000001241A12000-01-13
WO2004075645A12004-09-10
WO1996020709A11996-07-11
WO2006012835A12006-02-09
Foreign References:
US2443138A1948-06-08
US5364636A1994-11-15
US20070299034A12007-12-27
JP2007306902A2007-11-29
DE2005527A11971-08-19
EP1854472A12007-11-14
US20110313043A12011-12-22
GB2020957A1979-11-28
EP2386308A12011-11-16
US20120251589A12012-10-04
CN102669496A2012-09-19
Other References:
DATABASE WPI Week 200643, Derwent World Patents Index; AN 2006-415687, XP002719046
"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)", EFSA JOURNAL ANIMAL FEED (FEEDAP), 1 January 2011 (2011-01-01), XP055097753, Retrieved from the Internet DOI: 10.2903/j.efsa.2011.2007
WANG J-S ET AL: "Short-term safety evaluation of processed calcium montmorillonite clay ( NovaSil ) in humans", FOOD ADDITIVES AND CONTAMINANTS, TAYLOR AND FRANCIS, LONDON, GB, vol. 22, no. 3, 1 March 2005 (2005-03-01), pages 270 - 279, XP008095604, ISSN: 0265-203X, DOI: 10.1080/02652030500111129
RI-NA CHOI ET AL: "Preparation and Properties of Polypropylene/Clay Nanocomposites for Food Packaging", JOURNAL OF FOOD SCIENCE, vol. 76, no. 8, 1 October 2011 (2011-10-01), pages N62 - N67, XP055096337, ISSN: 0022-1147, DOI: 10.1111/j.1750-3841.2011.02351.x
INCORONATO ET AL: "Active systems based on silver-montmorillonite nanoparticles embedded into bio-based polymer matrices for packaging applications", JOURNAL OF FOOD PROTECTION, INTERNATIONAL ASSOCIATION FOR FOOD PROTECTION, US, vol. 73, no. 12, 1 December 2010 (2010-12-01), pages 2256 - 2262, XP008140589, ISSN: 0362-028X
SANCHEZ-GARCIA M D ET AL: "Natural micro and nanobiocomposites with enhanced barrier properties and novel functionalities for food biopackaging applications", TRENDS IN FOOD SCIENCE AND TECHNOLOGY, ELSEVIER SCIENCE PUBLISHERS, GB, vol. 21, no. 11, 1 November 2010 (2010-11-01), pages 528 - 536, XP027478693, ISSN: 0924-2244, [retrieved on 20100812], DOI: 10.1016/J.TIFS.2010.07.008
KUMAR P ET AL: "Preparation and characterization of bio-nanocomposite films based on soy protein isolate and montmorillonite using melt extrusion", JOURNAL OF FOOD ENGINEERING, BARKING, ESSEX, GB, vol. 100, no. 3, 1 October 2010 (2010-10-01), pages 480 - 489, XP027095237, ISSN: 0260-8774, [retrieved on 20100523]
AVELLA M ET AL: "Biodegradable starch/clay nanocomposite films for food packaging applications", FOOD CHEMISTRY, ELSEVIER LTD, NL, vol. 93, no. 3, 1 December 2005 (2005-12-01), pages 467 - 474, XP027769984, ISSN: 0308-8146, [retrieved on 20051201]
JO D H: "Confectionery containing black sesame fried in rice bran oil and coated with sticky coating material comprising refined sugar and millet jelly, and its preparation method", WPI / THOMSON,, vol. 2006, no. 47, 12 May 2005 (2005-05-12), XP002684807
LIN W: "Multi-flavored fried bread stick, has stock layer arranged with disk shaped, stripped shaped or circle shaped spiral fried bread sticks, and binder layer formed by covering granules or powder substances of proper sizes on fried bread sticks", WPI / THOMSON,, vol. 2011, no. 46, 8 June 2011 (2011-06-08), XP002684808
"Chronic Kidney Disease", article "Principles of internal medicine", pages: 1761 - 1771
JOHANNES HABER!E; NATHALIE BODDAERT; ALBERTO BURLINA; ANUPAM CHAKRAPANI; MARJORIE DIXON; MARTINA HUEMER; DANIELA KARALL; DIEGO MAR: "Suggested guidelines for the diagnosis and management of urea cycle disorders", ORPHANET JOURNAL OF RARE DISEASES, vol. 7, 2012, pages 32
HAEBERLE KN: "Psychological aspects of low protein diet therapy", BLOOD PURIF., vol. 7, no. 1, 1989, pages 39 - 42
SEREFOGLOU ET AL.: "Smectite clays as solid supports for immobilization of beta-glucosidase: synthesis, characterization and biochemical properties", CHEM MATER, vol. 20, 2008, pages 4106
MARROQUIN-CARDONA A ET AL.: "Characterization and safety of uniform particle size novasil clay as a potential aflatoxin enterosorbent", APPL CLAY SCI, vol. 54, 2011, pages 248
CARRETERO I.: "Clay minerals and their beneficial effects upon human health", APPL CLAY SCI, vol. 21, 2002, pages 155
DUCROTTE P ET AL.: "Symptomaytic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a randomized, controlled study", ALIMENT PHARMACOL THER, vol. 21, 2005, pages 435
WANG P ET AL.: "Novasil clay intervention in Ghanaians at high risk for aflatoxicosis: reduction in biomarkers of aflatoxin exposure in blood and urine", FOOD ADDIT CONTAM, vol. 25, 2008, pages 622
J BIOL CHEM., vol. 193, no. 1, November 1951 (1951-11-01), pages 265 - 75
J.NUTR., vol. 138, 2008, pages 2212
Attorney, Agent or Firm:
SPADARO, Marco et al. (Cantaluppi & Partners S.r.l, Piazzetta Cappellato Pedrocchi 18, Padova, I-35122, IT)
Download PDF:
Claims:
CLAIMS

1. Food product or a seasoning for food product for use in the reduction of food proteins in a subject, in particular a human subject, in need of a hypoproteic diet, characterized in that it comprises bentonite or montmorillonite.

2. Product according to claim 1, wherein said subject is selected from the group consisting of: a subject affected by diabetes, a subject affected by chronic renal failure, a subject affected by metabolic diseases, in particular urea cycle defect, and a subject undergoing a hyperproteic diet.

3. Product according to any one of claims 1-2, wherein said bentonite or montmorillonite is contained in an amount sufficient to substantially lower the enteral absorption of proteins.

4. Product according to claim 3, wherein said amount is comprised between about 3 and about 5 g for 100 gr of dry product or for 370 gr of rehydrated product, containing at least 30% of proteins.

5. Product according to any one of claims 1-3, wherein said bentonite or montmorillonite is contained in a ratio comprised between 1 : 3 and 1 : 15 with respect to the protein content of said product.

6. Product according to any one of claims 1-5, selected from the group consisting of dry products and frozen products.

7. Product according to any one of claims 1-5, selected from the group consisting of pasta, bread and substitutes thereof, for example sandwich bread, piadina, breadsticks, crackers, rusks, cereal flakes, any form of pasta, confectionery, for example dry and filled biscuits, plum-cakes, cakes and tarts, snacks and various bakery products, flours, desserts, ice creams, frozen desserts, ready meals, either pre-cooked, half-cooked or to be cooked; baby foods, in particular substitutes for mother's milk.

8. Product according to claim 7, which is a bakery product with flavouring granules sprinkled on the surface, characterized in that said granules are coated with a first layer of gum arabic and a second layer of bentonite or montmorillonite.

9. Product according to claim 8, characterized in that said gum arabic and said bentonite or said montmorillonite are in a weight ratio of 1 : 6.

10. Product according to any one of claims 8-9, characterized in that said granules are selected from the group consisting of poppy seeds, sesame, salt, onion, garlic, cheeses, aromatic herbs and tomato.

11. Product according to any one of claims 8-10, characterized in that said product is selected from the group consisting of breadstick, cracker, bread and snack.

12. Product according to any one of claims 8-11, characterized in that said flavouring granules are onion and/or garlic with a size of 1-2 mm.

13. Bentonite or montmorillonite for use in the reduction of food proteins in a subject, in particular a human subject, in need of a hypoproteic diet.

14. Bentonite or montmorillonite according to claim 13, wherein said subject is selected from the group consisting of: a subject affected by chronic renal failure, a subject affected by metabolic diseases, in particular urea cycle defects, and a subject undergoing a hyperproteic diet.

15. Package for a food product and/or a seasoning for food product, optionally comprising bentonite or montmorillonite as described in claims from 1 to 12, said package further comprising a bentonite or montmorillonite formulation for oral administration.

16. Composition comprising bentonite or montmorillonite for use in the reduction of food proteins in a subject, in particular a human subject, in need of a hypoproteic diet.

17. Composition according to claim 16, wherein said subject is selected from the group consisting of: a subject affected by chronic renal failure, a subject affected by metabolic diseases, in particular urea cycle defects, and a subject undergoing a hyperproteic diet.

18. Method for sequestering proteins from a food comprising the incorporation of bentonite or montmorillonite into said food.

Description:
FOOD PRODUCT OR A SEASONING THEREOF CONTAINING BENTONITE OR MONTMORILLONITE HAVING ACTIVITY OF METABOLIC PROTEIN LOAD REDUCTION

The present invention relates to food industry, in particular to specialty food products, more particularly to food products able to reduce the metabolic protein load, even more particularly to the production of special foods for subjects affected by chronic diseases.

The present invention further relates to the medical field, in particular to the treatment of diseases requiring hypoproteic diets.

Proteins are a fundamental component of human nutrition. In nowadays life, the dietary style includes a protein amount which, in some cases, may be excessive causing negative effects to health.

Protein intake occurs not only by plain protein-based foods, such as meats, but also through complex, industrially manufactured foods, for example confectionery.

Moreover, there are some pathological conditions, as explained more in detail below, which force the patient to a controlled protein intake, and even to eliminate some protein elements from the diet.

Chronic renal failure

Chronic renal failure is a progressive disease (from months to years) leading to the slow decline of kidney function of filtering the waste metabolites from blood. Among the main causes, diabetes and hypertension are mentioned. The treatment aims to reduce fluids, sodium and potassium from the diet, in addition to the pharmacological treatment of the underlying disease, up to dialysis. It is important to reduce the protein load that the kidney has to bear and this is made through accurate, even severe, dietary restrictions (Principles of internal medicine, Harrison's 17th ed. "Chronic Kidney Disease", pages 1761-1771)

Urea cycle defects

Urea cycle defects (UCD) are genetic defects affecting ammonia detoxification and arginine synthesis. It is a rare disease, where patients have hyperammonemia immediately after birth, or during any subsequent stage of the life with fatal outcome or severe neurological impairments, when surviving . Despite the availability of several therapies and liver transplant, the outcomes a re poor. The acute treatment of hyperammonemia also contemplates the rigorous monitoring of the protein balance, which should avoid the protein intake and at the same time the protein catabolism, ensuring a suita ble energy supply. The essential mainstay in the long-term management of the disease is the maximum reduction of nitrogen load in the urea cycle. The protein balance is highly complex, since both the ind ivid ua l response of the subject and its life stage (child, adolescent, adult, pregnancy) have to be taken into account. An excessive protein restriction can also be detrimental . For a review of this disease, see Johannes Haberle, Nathalie Boddaert, Alberto Burlina, Anupam Chakrapani, Marjorie Dixon, Martina Huemer, Daniela Karall, Diego Martinelli, Pablo Sanjurjo Crespo, Rene Sa nter, Aude Serva is, Vassili Valayannopoulos, Martin Lindner, Vicente Rubio and Carlo Dionisi-Vici Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases 2012, 7 : 32. Diabetes

Diabetes Mellitus or DM comprises a group of metabolic disorders, which have in common a persistent instability of blood glucose level, ranging from hyperglycemic conditions, which are more frequent, to hypoglycemic conditions.

Type 1 diabetes is characterized by the destruction of pancreatic B cells (lymphocytes CD4+ and CD8+ and macrophage infiltration in the pancreatic islets), usually leading to the association with insulin deficiency. On the contrary, type 2 diabetes, which is much more common, has a non-immune pathogenesis and may have several causes. The percentage of world population affected by diabetes has been estimated to be around 5%, about 90% thereof has type 2 DM . In Italy, the percentage of individuals affected by such disease is, on average, 3%.

The guidelines for performing a rational therapy in the case of uncomplicated DM contemplate that the patient adopts a lifestyle (diet and physical exercise) which is appropriate and useful to the pharmacological treatment being set up.

A crucial factor in diabetes therapy is the diet. In particular, it is required to eat foods with low-glycemic index (a parameter which indicates the rate of the glycemia increase following to the administration of a food amount containing 50 g of carbohydrates) and to balance the various foods of the diet.

A quite common risk factor related to diabetes, after a certain time period, is the onset of a nephropathy stage mainly caused by the presence in the diet of an excessive protein amount; this leads, in the long term, to a kidney impairment due to the high uric acid levels in urine, derived from digestion and degradation of the ingested proteins.

Therefore, diabetic subjects require a detoxification of the excess ingested proteins. Hyperproteic diet (athletes, slimming diets ' )

The hyperproteic diet is a particular food regimen characterized by a reduced consumption of carbohydrates combined with a high protein and fat intake.

This kind of diet is often recommended to athletes, in particular for strength sports (rugby, weight lifting, sprint races, body building, etc.) players, to promote the muscle mass enhancement and fat loss.

However, these hyperproteic food regimens induce, from a metabolic point of view, due to the fat and protein oxidation for energetic purposes, ketosis or acetonemia (build-up of ketone bodies in the blood), hyperuremia (a toxic condition characterized by protein catabolite build-up, such as urea, in the blood), hyperaminoacidemia, hyperammonemia, hyperinsulinemia, nausea, diarrhoea and even death. Furthermore, the lipid-protein unbalanced diets are not devoid of severe digestive problems (spasms, flatulence, diarrhoea, constipation, etc.).

Hyperproteic diets are also used for losing excess weight, due to their effect on the fat mass reduction. In this case they may also cause different side effects, such as those mentioned above.

Therefore, in both the above-cited circumstances, the body needs of "detoxification" periods from protein diet.

For this purpose, it is required a food which, even within a balanced dietary regimen, would promote the suppression or reduction of the excess protein load.

Hypoproteic diets

Hypoproteic diets need a remarkable effort by the patient in order to follow the prescribed regimen. Hypoproteic foods are usually less attractive and the dosage regimen ant times of the diet may lead the patient to disregard the prescribed regimen. The lack of psychological satisfaction typical of an attractive and convivial eating may expose the subject to the risk of depression and generally to a reduced quality of life (Haeberle KN; Psychological aspects of low protein diet therapy; Blood Purif. 1989;7(l) : 39-42) .

Preparing low-protein content meals requires a high knowledge, awareness and capability. The hypoproteic dietary regimen followed at home is difficult to be practiced and segregates the patient from the convivial food-sharing.

The food industry developed various meals for hypoproteic diets which by now potentially encompass a wide range of foods and ready meals. Seemingly, these foods could also satisfy the psychological aspect of food. However, the raw materials being necessarily used are still unable to provide foods with satisfactory organoleptic properties. Cultural aspects of food have also to be considered, and in some societies, the hypoproteic diet meets remarkable reluctances, at least to a strictly followed regimen.

Moreover, it has to be considered that these foods are usually more expensive than common analogues and, when they are reimbursed by the national health care system, they affect the general costs of healthcare.

In the Italian diet, or more broadly meant as Mediterranean diet, pasta plays a fundamental role, and its complete elimination from the patient's diet has strong, even psychological, implications.

A kind of pasta suitable for these subjects is made with specific flour mixtures. Among them, pre-cooked rice flour, pre-cooked chickpea flour, bean flour, soya flour, buckwheat flour and maize flour are cited. The problem related to the use of such kind of flour mixture is that they do not bind each other and, consequently, the dough cannot be extruded.

To date, according to the knowledge of the present inventors, there is no way which allows the patients undergoing hypoproteic dietary regimens, to disregard them without incurring in the risk of worsening of the disease or impairing of the therapeutic progress.

The aim of the present invention is to solve the problems known in the art.

Bentonite is a phyllosilicate (AI 2 0 3 -4Si0 2 -4H 2 0), a clay mineral mainly consisting of montmorillonite, calcium or sodium. In the food sector it is used combined with psyllium for removing residuals and plaques of mucus and faeces existing far back in the gut.

Hereinbelow, the terms bentonite and montmorillonite are also expressed by the general term "clay", being understood that the present invention relates to bentonite and montmorillonite.

In oenology field, clay is used for clarifying musts, namely it is added so that all the more coarse suspended parts would deposit on the barrel bottom and, by an upper pouring method, a clear must can be thereby put to fermentation.

The clay is also used in wines ready for bottling, since a dosage thereof of around 50 gr per hectolitre of wine allows its protein stability.

This clay effect is due to its property of protein flocculation; namely, it is capable to bind the proteins dissolved in the wine and to bring them to the barrel bottom.

Montmorillonite, the main component of bentonite, is a clay mineral, consisting of hydrated calcium, aluminium, magnesium and sodium silicate, with a layered structure having a high ability of absorbing water and gases (H 2 , CH 4 , C0 2 ) and a high cation- exchange capacity (Serefoglou and et al. Smectite clays as solid supports for immobilization of beta-glucosidase: synthesis, characterization and biochemical properties; Chem Mater 2008;20 :4106). The layered structure and the cation- exchange capacity allow a stable entrapment of both high molecular weight proteins (for example albumin) and low molecular weight molecules (for example aflatoxins) (Marroquin-Cardona A et al. Characterization and safety of uniform particle size novasil clay as a potential aflatoxin enterosorbent. Appl Clay Sci 2011;54:248). For this reason, montmorillonite is used in pharmaceutical and food industry as stabilising agent or addictive in the manufacturing of products to be used in medical and veterinary field and in human nutrition (Carretero I., Clay minerals and their beneficial effects upon human health; Appl Clay Sci 2002;21 : 155). Clinical studies showed that per os administration of montmorillonite improves the gastro-intestinal clinical picture in subjects with Crohn's disease (Ducrotte P et al. Symptomaytic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a randomized, controlled study; Aliment Pharmacol Ther 2005;21 :435) and sequesters the aflatoxins existing in improperly stored foods, primarily in poor countries, dramatically reducing the diffusion of these mycotoxins (Wang P et al. Novasil clay intervention in Ghanaians at high risk for aflatoxicosis: reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam. 2008;25: 622).

Further uses of montmorillonite in pharmaceutical industry are known.

WO9620709 discloses the use of clays, such as bentonite, for the treatment of diarrhoea or intestinal infections due to the acid build up in the gastro-intestinal tract caused by carbohydrate fermentation.

EP2386308 discloses a pharmaceutical composition for the targeted delivery in the intestinal tract of adsorbent agents, in order to prevent the intestinal absorption of an excess of antibiotics or other substances detrimental for the bacterial flora.

Montmorillonite is generally used for absorbing toxic substances, see for example WO200612835.

In US20120251589 a device containing a sponge material which, when ingested, absorbs the meal digested by the stomach is disclosed. Montmorillonite, among the several sponge materials, is mentioned. This device is conceived for a generalized nutrient absorption in order to lower the amount of ingested calories and it is recommended for obese subjects.

Different uses of montmorillonite in zootechnical field are also known, for example for preparing feed for breeding animals for human consumption. CN 102669496 describes the use of said clay for reducing the intestinal absorption of mycotoxins.

The prior art provides no indications or suggestions about the possible role of montmorillonite in an effective and controlled protein absorption in a complex matrix, such as a food, and does not allow at all to predict a physiological and therapeutic effect in humans.

Summary of the invention

It has now been found that by introducing in foods a proper amount of bentonite or the main component thereof, montmorillonite, the above-cited problems can be solved due to its protein binding property.

The aforementioned problem that people affected by diseases requiring a hypoproteic diet have in common, for example chronic renal failure, even resulting from diabetes, urea cycle defects, but also healthy people undergoing hyperproteic diets, for example athletes or subjects generally following a hyperproteic diet, is solved by the present invention by adding a clay percentage, specifically bentonite or montmorillonite, to a protein food. The clay, indeed, by binding the food proteins, prevents the absorption thereof through the gut, thereby reducing the protein value of the ingested food.

Therefore, it is an object of the present invention a food product or a seasoning for said food product (hereinafter collectively also referred to as "product") for use in the reduction of the metabolic protein load, specifically in the reduction of the enteral absorption of food proteins, in a subject, in particular a human subject, in need of a hypoproteic diet, characterized in that it comprises bentonite, or montmorillonite. It is another object of the present invention, a food product or a seasoning for said food product containing bentonite or montmorillonite for use in the nutrition of subjects affected by diseases requiring a hypoproteic diet, such as diabetes with renal complications, chronic renal failure, metabolic diseases, in particular when the therapy or treatment thereof requires a hypoproteic diet, such as urea cycle defects.

It is another object of the present invention, a food product or a seasoning for said food product containing bentonite or montmorillonite for use in the nutrition of subjects undergoing a hyperproteic diet.

The present invention further provides a method for stably sequestering the food proteins, which comprises incorporating bentonite or montmorillonite in said food. It is understood that in the following specification and claims, the terms "product" or "food product" also comprise a seasoning for said product.

These and other objects will be described in detail below, also by means of examples and figures.

Detailed description of the invention

In figures 1 and 2 the graphs of the result of the experiment disclosed in Example 4 are shown.

In accordance with the present invention, by "bentonite" is meant an aluminium phyllosilicate in its various forms, for example sodium, potassium or calcium.

In accordance with the present invention, by "montmorillonite" is meant the main component of bentonite.

All the terms being used in the description of the invention are well-known to the skilled in the art.

According to the present invention, the food product or a seasoning thereof comprises bentonite or montmorillonite in an amount sufficient for substantially decreasing the enteral protein absorption.

For the purposes of the present invention, the term "substantially" means a decrease of the enteral protein absorption capable to provide a benefit to the patient or healthy subject's conditions related to the high protein load. Such benefit may be a feeling of better well-being than the status prior to the administration of the product according to the present invention, an objective or subjective amelioration of the disease symptoms related to the high protein load, up to the gradual resolution of the disease or a standard recovery of protein metabolism. It is understood that in the event of pathological occurrences, the present invention can be also carried out concomitantly and as integration of known therapeutic methods.

As shown in the examples, said amount can be easily assessed by an ordinary skilled technician through basic tests on the specific product. In an exemplary embodiment, a suitable amount of bentonite or montmorillonite is comprised between about 3 and about 5 g per ready meal, i.e. per 100 gr of dry product and 370 gr of re-hydrated product consisting of at least 30% of proteins.

The product according to the present invention is selected for example from the group consisting of dry products and frozen products. Examples of such products are pasta, bread and substitutes thereof, for example sandwich bread, piadina, breadsticks, crackers, rusks, cereal flakes, any form of pasta, confectionery, for example dry and filled biscuits, plum-cakes, cakes and tarts, snacks and various bakery products, flours, desserts, ice creams, frozen desserts, ready meals either pre-cooked, semi- cooked or to be cooked.

In an embodiment of the invention, the bentonite or montmorillonite is comprised within a seasoning for food product.

In an embodiment of the invention, the food product is a bakery product with flavouring granules sprinkled on the surface, characterized in that said granules are coated by a first layer of gum arabic and a second layer of bentonite or montmorillonite. In a preferred case, said gum arabic and said bentonite or montmorillonite are in a weight ratio of 1 : 6. Examples of said flavoured granules are poppy seeds, sesame, salt, onion, garlic, cheeses, aromatic herbs and tomato. Conveniently, said bakery product with said granules is for example a breadstick, cracker, bread and snack. In a particularly preferred embodiment, said flavouring granule is onion and/or garlic, with a size of 1-2 mm. Such dose can be considered as the daily dose, and can be comprised in a unique food piece, for example a snack or dessert, or it can be divided into several pieces collected into a package, for example of biscuits or breadsticks or crackers, or it can be subdivided in portions, for example in 60-100 g of pasta.

In a first preferred embodiment of the invention, the food product is a specially formulated farinaceous product, preferably pasta. The pasta being prepared according to the present invention, can be a known kind of pasta, for example for celiac subjects or, in general, for subjects in need of a hypoproteic diet, in this case it has the advantage to bind the different flours and allow a standard processing (in particular the extrusion). Moreover, the pasta thus obtained is more resistant to over-cooking and is definitely more attractive. Said technological advantage also exists for all the other farinaceous products.

Examples of flours being used for this kind of specific products are: rice flour, chickpea flour, bean flour, soya flour, buckwheat flour, Manitoba flour.

In another preferred embodiment of the invention, the food is in the form of a bakery product comprising bentonite or montmorillonite with flavouring granules sprinkled on the surface, characterized in that said granules are coated by a first layer of gum arabic and a second layer of bentonite or montmorillonite.

Said product, besides granules, may contain inside a dose of bentonite or montmorillonite to thereby achieve the recommended daily dose.

The flavouring granules being treated according to the present invention are of various kinds known in the food industry. A merely illustrative list comprises salt, sesame seeds, poppy, salt, onion, garlic, cheeses, aromatic herbs, tomato, etc.

The bakery product on which the granules according to the present invention are sprinkled can be of any kind, and in a merely illustrative list said product is selected from the group consisting of breadstick, cracker, bread, various snacks.

Preparing the food product does not require any particular expedient, except for adding bentonite or montmorillonite during preparation. In the specific case of flavouring granules, the present invention provides a method for manufacturing said granules and the flavoured food.

According to the present invention, the preparation of the flavouring granules is carried out through a process comprising the following steps:

a. adding an aqueous gum arabic solution to a plurality of granules;

b. mixing said granules until they are disaggregated and obtaining granules coated with gum arabic;

c. adding bentonite or montmorillonite to said granules from step b) until they are disaggregated and obtaining the coated granules.

In the above-cited process, the disaggregation is preferably complete.

In step c), bentonite or montmorillonite is preferably added as powder.

In an embodiment of the invention, the weight ratio between gum arabic and bentonite or montmorillonite is 1 : 6. For a better adhesion of granules, the bentonite or montmorillonite can be increased.

The flavouring granules of the present invention can be used for sprinkling bakery products. Alternatively, the flavouring granules can also be incorporated in any food product, exploiting the advantage provided by the present invention in terms of preserving the characteristic flavour of the granule.

Said granule is prepared through a process comprising the following steps:

a. adding an aqueous gum arabic solution to the granules;

b. mixing said granules until they are completely disaggregated and obtaining granules coated with gum arabic;

c. adding bentonite or montmorillonite to said granules from step b) until they are completely disaggregated and obtaining the coated granules;

d. sprinkling the coated granules on the product to be baked and optionally incorporation;

e. baking and obtaining the bakery product.

It is another object of the present invention a food product comprising said flavouring granules.

In an embodiment of the invention, a mixture of 30-40% gum arabic and water is separately prepared.

The flavouring granules are placed in a kneader-mixer and the mixture of gum arabic and water is slowly added thereto, while the mixer is working. In an exemplary embodiment of the invention, the mixture consists of 50 g of gum per 300 ml of water for 10 kg of granules to be coated. The gum arabic amount is also a function of the granule size, the smaller the granule, the greater the surface to be coated. The mixing is continued in alternating directions until the granules coated with gum arabic are completely disaggregated.

Next, if desired in the same mixer, and in any case during mixing, powdery bentonite or montmorillonite is added, and the mixing is continued until a complete disaggregation.

Granules have now a double coating, wherein the first coat is gum arabic, contacting with the granule, and the second coat, the outer one, is bentonite or montmorillonite. The granules according to the present invention are ready-to-use and can be sprinkled on the food product according to known techniques, or incorporated in the product itself.

In an exemplary embodiment of the invention, the bakery product is prepared according to standard methods.

For the sake of example, the breadstick preparation is described. The ingredients are placed in a dough mixer and processed. The dough is then conveyed to the extruder in order to form breadsticks. The extruder is connected to the oven by transferring means, for example a belt. The breadsticks are moved from the extruder to the oven and during the transfer they are superficially treated with a bath of water and starch and subsequently sprinkled with granules according to the present invention. The surface treatment with water and starch is preferably carried out by spraying, through a suitable diffuser and the sprinkling can be made by means of a hopper, optionally equipped with a vibrating sieve.

The water and starch solution is for example a 7% solution of maize starch. The starch concentration is not critical, and is established based on the bakery product to be prepared.

The breadsticks are thus placed in the oven for baking according to the standard methods and are next conveyed to the packaging step.

The ordinary skilled technician can of course adopt all the proper process and plant variants depending on the desired product, for example cracker, snack or various kinds of bread, as such variants are well-known in the field.

In another embodiment of the invention, the flavouring granules are of onion and/or garlic. These granules have to be conveniently treated so as to not impair the friability of the final bakery product.

The optimum size of onion and/or garlic granules in bakery products such as breadsticks, crackers and snacks has been found to be of 1-2 mm, instead of the standard 0.01 mm.

Therefore, it is also an object of the present invention a flavouring garlic or onion granule for foods, in particular for bakery products, having a 1-2 mm size and coated as disclosed above.

It is evident that the present invention may be applied irrespective of the shape and size of granules, which will be consistent with the use of the selected food product.

When the invention is also applied to foods for the diabetic subject, particular attention has to be paid to the carbohydrate content. The foods containing bentonite or montmorillonite according to the present invention have the advantage to decrease the protein load, which represents, in the case of the diabetic subject, a possible renal system complication. The bentonite or montmorillonite doses are the same as seen above.

In another embodiment, the present invention provides foods containing bentonite or montmorillonite for use in diets "detoxifying" from the protein load, for example the hyperproteic diets. According to this embodiment of the invention, the food containing bentonite or montmorillonite is administered at the end, or approximately at the end, of the diet, or during the same, if the need to reduce the protein load for an intermediate period should occur, without have to change the dietary habits. In this case, the bentonite or montmorillonite dose per meal, i.e. per 100 g of dry product or 370 g of hydrated product, is comprised between about 20 and about 25 g. This range of doses can be applied to a food having about 40 g of proteins/100 g of food.

In a preferred embodiment of the invention, these foods containing bentonite or montmorillonite are useful in hyperproteic diets for athletes, when the need to intake a high protein amount ceases, for example following to the agonistic effort.

In a preferred embodiment of the invention, these foods containing bentonite or montmorillonite are useful in hyperproteic diets for weight control, for example over an intermediate period in order to relieve the protein load to the renal system.

In another embodiment, the present invention contemplates the administration of bentonite or montmorillonite along with meals for reducing the metabolic protein load. Therefore, it is another object of the present invention the bentonite or montmorillonite for use in the reduction of the metabolic protein load, in a subject in need of said reduction, in particular when pathological conditions related to such metabolic protein load occur.

According to this aspect of the invention, the clay can be administered at different times during the day. Preferably, it is administered along with the meal, for example by adding it to the food, or a drink. Conveniently, the bentonite or montmorillonite can be formulated in easily administrable forms by oral route, for example granules, tablets, operculum, hard or soft capsules, packets, suspensions.

Another embodiment of the present invention contemplates a package for food product and/or seasoning for food product, optionally comprising bentonite or montmorillonite according to the present invention, said package further comprising a bentonite or montmorillonite formulation for oral intake. Said package may also comprise the instructions for using bentonite or montmorillonite to reduce the metabolic protein load.

Alternatively, the bentonite or montmorillonite can be administered in a composition of pharmaceutical, nutritional, nutraceutical or food supplement type suitable for oral administration, for example tablet, capsule, granules, packets, cachets, ready-for-use or freshly-made suspension.

In an exemplary embodiment of the present invention, the ratios (weight/weight) between montmorillonite and proteins in the administered meal can range between 1 : 3 and 1 : 15. These ratios can be adjusted depending on the protein content of the administered meal.

According to the present invention, the bentonite or montmorillonite can be administered in different manners: along the meal, or before or after the meal. In the two latter cases, it would be considered the kind and the amount of the meal, the time of digestion and transit thereof. It would be paid attention to administer the montmorillonite nor too earlier than meal, in order to prevent the montmorillonite from contacting the latter; neither too later than meal, in order to avoid that the process of digestion and protein absorption is already begun.

These compositions, for the present use, are a further object of the present invention. The present invention provides the advantage to allow the subjects suffering from diseases for which they have to undergo a severe dietary hypoproteic regimen to have a regular and more attractive meal, re-establishing, at least temporarily, the psychological and convivial pleasure.

The subjects who can take advantage from the present invention generally suffer from the above-mentioned diseases, for example renal failure or metabolic diseases, for instance urea cycle defects.

The economic benefit, both for patients and public health services, derived from the lower costs for special foods has to be taken into account.

The present invention is also applicable to those subjects that, in general, whish to follow a hypoproteic diet.

Another embodiment of the present invention comprises a package for a food product and/or a seasoning for food product, optionally comprising bentonite or montmorillonite, said packing further comprising a bentonite or montmorillonite formulation for oral administration .

In an embodiment of the invention, the montmorillonite ca n be formulated in baby foods, for example substitutes for mother's milk.

It is a further object of the invention a method for reducing the food proteins in a subject, in particular a human subject, in need of a hypoproteic diet, comprising the administration to said subject of a food product or a seasoning for food product comprising bentonite or montmorillonite.

In an embodiment of such method, sa id subject is selected from the group consisting of: a subject affected by diabetes, a subject affected by chronic renal failure, a subject affected by metabolic diseases, in particular urea cycle defect, and a subject undergoing a hyperproteic diet.

In accordance with this object of the invention, sa id product according to any one of claims comprises a bentonite or montmorillonite a mount sufficient for substantially decreasing the enteral protein absorption, for example said amount is comprised between about 3 and about 5 g per 100 g r of d ry product or 370 gr of re-hydrated product, containing at least 30% of proteins. In particular, said bentonite or montmorillonite is in a ratio comprised between 1 : 3 and 1 : 15 relative to the protein content of said product.

The food product or the seasoning thereof a re disclosed above.

In another embodiment of the invention, sa id method comprises administering to said subject bentonite or montmorillonite in a distinct form tha n the food product, preferably in the form of composition disclosed above a nd by the ways explained above.

The following examples further illustrate the invention . Example 1 - Pasta

A flour mixture with the following composition was prepared :

400 gr of pre-cooked rice flour

300 gr of pre-cooked chickpea flour

300 gr of bean flour

500 gr of soya flour

500 gr of buckwheat flour

127 gr of extra-pure airfloated clay (bentonite)

100 gr of fine salt

Water as needed for extrusion.

The dry ingredients were mixed for 10 minutes so that the clay was uniformly dispersed, the water was thus slowly added to the dough mixer and after few minutes the pasta was extruded at a temperature of the extruder of around 68-75 °C.

After drying, the pasta did not clump and remained cohesive.

The pasta cooking time was very fast, about 4 minutes.

The taste is good, with a preponderance of chickpea and soya flavour.

La pasta being obtained has the following composition : 58% of proteins, 32% of low- glycemic index carbohydrates and 10% of fats. Gluten is absent in the pasta.

A gluten-free pasta, thus suitable also for celiac subjects, but at the same time with good cohesive and organoleptic properties was thereby obtained.

Example 2 - Seasoning containing bentonite

A pasta dish by using traditional pasta (not suitable for celiac subjects - samples 1-3) and pasta for celiac subjects (samples 4-5) and a traditional seasoning (seafood "pescatora" sauce) was prepared. The bentonite was added to the various samples in different steps, in order to assess the effect on the protein content.

5 dishes, respectively 1) without addition of clay, 2) with addition of clay to the seasoning during its cooking, 3) with addition of clay to the seasoning on the pasta after cooking, 4) without addition of clay, 5) with addition of clay to the seasoning during its cooking were prepared.

A sample from each preparation was taken away and after whipping, the fluid alone was extracted, on which the protein content was assessed.

The following Table 1 shows the results.

Table 1

n.d. = not detectable

From the Table it can be understood how the addition of bentonite to the seasoning, both during its cooking, and directly to the pasta after cooking, leads to a substantial reduction of the total protein content.

Two additional samples were prepared as shown above, on which the proteins to the total mass were analysed.

Table 2 shows the results

Table 2

The result shows that the clay stably bound both proteins and gliadi

Example 3 - Breadsticks with flavoured granules

A breadstick dough with the following composition was prepared : Manitoba flour 0 100.0 g

Soft wheat flour 0 150.0 g

Fine salt 4.3 g

Vegetable fat 50.0 g

Yeast for bread 3.0 g

The bentonite was added to the dough in an amount suitable for obtaining a final content between about 3 and about 5% per 100 g of dry product.

Separately, the flavoured granules were prepared according to the following process. 10 kg of hulled sesame seeds were placed in a mixer-blender.

50 g of gum arabic were mixed in 300 ml of water.

The blender was started and the mixture of water and gum arabic was slowly added. The blender is kept operational, by alternating the rotational direction, until the seeds are disaggregated.

During the mixing, 300 g of powdery bentonite were added in portions and the mixing is continued until complete disaggregation.

Similarly, the salt and poppy seed granules were prepared.

After extrusion and formation of breadsticks, a 7% solution of water and maize starch was brushed on the surface.

The breadsticks surface was sprinkled with salt granules of medium-grain and with hulled sesame seeds prepared as above.

After leavening, the breadsticks were placed in the oven and firstly cooked for four minutes at 390°C and then at 220° for additional fifteen minutes.

Example 4

In -vitro tests

Samples of montmorillonite and freeze-dried proteins from cow's milk serum for human nutrition (whey protein) in w/w ratios of 1 : 3, 1 : 5, 1 : 15 and a sample of protein alone were prepared. The samples were dissolved in acetate buffer 0.1 M pH 5 and incubated under shaking at room temperature for 1, 10, 30 and 60 minutes. After centrifugation of the mixtures at 13,000 rpm and recovering of the supernatant, the free protein amount, was measured by Lowry's colorimetric method (J Biol Chem. 1951 Nov; 193(l) : 265-75). The protein concentration is expressed in mg/ml. The extent of the montmorillonite absorption at the different ratios was compared with the protein sample of control, and the differences were statistically assessed by t-test. The montmorillonite stably retains the food proteins beta-lactoglobulins, alpha lactoalbumins, and at the montmorillonite-proteins ratios (p/p) equals to 1 :3, 1 : 5, 1 : 15 a protein sequestering of 50, 27 and 0 %, respectively, is obtained.

Example 5

In vivo study

Upon informed consent, 25 healthy volunteers aging between 25 and 30 (12 M and 13 F) were enrolled.

All of the subjects started the study in the morning under fasting conditions and were divided into 4 groups: 10 subjects ate a standard protein meal (whey protein) (15 gr in 200 ml of water); 5 a mixture consisting of montmorillonite + proteins (5 gr + 15 gr, 1 : 3) ; 5 a mixture consisting of montmorillonite + proteins (3 gr + 15 gr, 1 : 5); 5 a mixture consisting of montmorillonite + proteins (1 gr + 15 gr, 1 : 15) . Furthermore, 5 subjects from group 1 : 5 performed a cross-over with the administration of 15 gr of proteins. A control group ate 15 gr of protein alone. Each volunteer was inserted with a cannula needle (hand dorsal vein) that allows to taking six blood samples of three ml (overall 18 ml). The blood samples were taken according to the following scheme: before eating the mixture; and at 30, 60, 90, 120, 180 minutes after eating the mixtures. The blood samples were centrifuged and the plasma frozen in two aliquots at -80°C. The five subjects being assessed a first time for the ratio 1 : 5 montmorillonite-proteins, were subsequently assessed after 30 days, by administering the protein alone (15 gr) in order to verify the actual effect of montmorillonite upon the same individuals.

The plasma samples were analysed by mass spectrometry (Agilent HP5973 Mass Spectrometry) for measuring the concentration of 12 amino acids (ALA, GLY, LEU, PHE, Ac GLU, GLU, TYR, THR, SER, PRO, CYS, MET) in the 6 plasma samples from each subject (J.Nutr. 2008; 138: 2212). The plasma concentrations of every amino acid were compared among the study groups and statistically assessed by ANOVA test.

The data show an amino acid decrease, which is a direct consequence of the reduction of the protein meal absorption.