Composition for appetite control and management and weight regulation

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to food and chemical-pharmaceutical industry, namely to creation of a concentrated oil/water emulsion of replacement fat of zero caloric content intended for both appetite control and management, and weight regulation. A composition for appetite control and management, and weight regulation, represents the concentrated emulsion containing replacement fat with zero caloric content selected from a group of saccharose polyesters consisting generally of mixed saccharose octa-, hepta- and hexaesters, triglycerides of caprylic/capric fatty acids, edible Vaseline oil, an emulsifying stabiliser selected from the group: gum arabic, saponin, modified starch, a flavour additive, a preservative, vitamin A, beta carotene and water taken in certain proportions.

EFFECT: received composition shows high functional activity of the developed concentrated emulsions in the prescribed sparing mode of therapy "ГЛ".

3 cl, 1 tbl

 

The invention relates to the food and pharmaceutical industry, namely: the creation of a concentrated emulsion of the type oil/water-based Jerusalemites with zero calorie designed as to control appetite and weight regulation, and as a raw material for biologically active additives to food and/or pharmaceutical preparations, dietetic and functional foods to reduce calorie fat-containing products.

The emulsion reduces the absorption of bile acids in the small intestine and has a blocking effect against the enterohepatic circulation of bile acids.

The emulsion can be attributed to pharmaceutical preparations which can be used in medicine for the normalization of lipid metabolism and the physiological state of the organism as a whole in the prevention and conservative treatment of various diseases, which are based on such a pathogenetic factor as dyslipoproteinemia (DLP) and, in particular, hyperlipidemia (CH) (Thompson G.R. Handbook of heperlipidemia. London, 1991), as well as to restore the natural mechanism of cholesterol homeostasis and normalize bile-acid metabolism.

Preventive and therapeutic effects on the body emulsions with functional properties is to not upset the usual mode of life, "gently" to monitor and control appetite, regulate weight and gradually bring to normal lipid spectrum of blood plasma (cholesterol, triglyceride, low density lipoprotein and others) and thereby prevent the development of pathogenic factors such as DLP (RF Patent N 2008821, AV 17/00, 14.10.91, Ross R., Harker L. Hypelipidemia and atherosclerosis, Science, 1976. Vol.193. pp.1094-1100).

Known application in pharmacological therapy DLP and, in particular, hyperlipidemia (HL) drugs that reduce the absorption of bile acids in the small intestine (cholestyramine, colestipol, polifan, chitosan, etc.) (Lipid Research Clinics Program // The Lipid Rescarch Clinics Coronary Primary Prevention Trial results. 1. Reduction in incidence of coronary heart disease // JAMA. - 1984. - Vol.251. - P.351-364). However, there is a risk of development of various complications and there are contraindications, especially with long-term use of the drugs of this group.

Now proven to be the most effective in the prevention and treatment of DLP is emulsion-based form vaseline (white) oil.

Pasta "Visant With" drug "Ficant. Leaflet company LTD. Penta Honey", RF patents №2008821; 2054931; 2128991, RF Patent №2008821, AV 17/00, 14.10.91, RF Patent №2054931, A61K 9/107, 01.06.94) is a vaseline-Pechino-agar emulsion and is used in the treatment and prevention DLP together with choleretic drug is mi and, if necessary, with drugs, enhance intestinal peristalsis (Yablokov Mrs x, Petukhov V.A., Kuznetsov MR, Krayushkin AV Dyslipoproteinemia and atherosclerosis. New perspectives for diagnosis and treatment. Ed. by Acad. The RAMS Savelyeva B.C. - M., 1996, pp.69-76).

Vaseline edible oil, encapsulated inside the pectin-agar shell dissolves and absorbs bile acids, and then transports them into the large intestine. Bile acids along with the oil removed from the colon with feces. Insufficient return of bile acids to the liver (as opposed to a healthy person) requires synthesis of a new portion of bile. This requires cholesterol, which is the basis of bile acids. He comes from blood plasma and other depot is converted into bile acids and leaves the liver together with gall. Thus, restores the natural mechanism of circulation of bile acids and fecal excretion of cholesterol.

Molecules of polysaccharides, pectin and agar, are part of the drug is not absorbed in the small intestine, as resistant to the action of various enzymes. An important feature of these polysaccharides is the ability to bind heavy metals and toxins that can be attributed to the drug to the active chelators.

The main advantage of the paste Ficant-in comparison with the known pharmacological trail is t to rebuild the natural mechanism of cholesterol homeostasis.

Paste Ficant-take 1 once a week dose of 200 g of paste per day for 4-12 months. This corresponds to 75-80 g of paraffin oil with a single admission.

The product contains the following components in wt.%: vaseline oil - 38.5, pectin - 6,0, agar - 0,5, jelly with carrot - 14,5, distilled water - the rest.

The main disadvantage paste Ficant-is the presence in the composition of the synthetic vaseline edible oil (a mixture of saturated hydrocarbons - oil fraction), which is hard to call a food product for everyday use. In addition, it is known that prolonged use of mineral oil, even in small doses, can disrupt the digestive process.

Recommended therapeutic daily dose consumption of mineral oil as a laxative is 1-3 tablespoons per day (40-50 ml), and consumed daily dose of mineral oil in the pasta Ficant-With almost 1.5 times higher than the adequate therapeutic dose, as noted above.

Therefore, such a synthetic product may not be recommended for use as a nutritional diet product to control appetite control and weight management in "soft" prevention of obesity.

An obvious disadvantage paste Ficant-is also overestimated the amount of dietary fiber recommended in the daily dose, which is - 13 g, which exceeds the maximum adequate level of daily consumption of Pectin and Agar almost 2.5 times (Rational nutrition. Recommended levels of consumption of food and biologically active substances. Methodology N MP 2.3.1.1915-04 dated 2 July 2004).

Limited shelf life under normal conditions is only 2 months, is also the added disadvantage paste Ficant-C.

The closest solution to the proposed invention is a beverage in the form of a concentrated emulsion based liquid Jerusalemites grade Olestra-Olean (dietary fat) with zero calories, which by its chemical nature is the product of the synthesis of sucrose and vegetable oils and is a liquid not absorbed in the body product in the form of a mixture of polyesters of sucrose (Technical information OLEAN company The Procter & Gamble Co.).

The emulsion is used as a substitute for dietary fat for fat and hypercholesterinemia patients.

In the concentrated beverage composition in the form of monocroptophos emulsion-based Jerusalemites includes: representing a liquid the consistency of the sucrose polyester (a mixture of hexalate [77138-73-9], septolete [77138-74-0] and octaoleate [34816-23-4] sucrose) in the amount of 43.5 wt.%, solid palm oil - 10.9 wt.%, sucrose - 10.5 wt.%, milk protein - 3.8 wt.%, poly is literally ether (average 3 glycerolic unit, With14-C18fatty acid esters) and 1.8 wt.%, propylene glycol ether (85 wt.%, monopalmitate [29013-28-3]) - 1.8 wt.%, Xanthan of gum to 1.0 wt.%, powder vanilla - 0.3 wt.%, flavor - 0.1 wt.%, potassium sorbate - 0.06 wt.%, citric acid is 0.04 wt.%, water - to 26.2 wt.% (European patent EP 0069412 (A1), 1983-01-12).

The disadvantages of this emulsion are: the presence in the diet product solid palm oil in concentrations of more than 10 wt.%, which is an additional source of excess calories along with carbohydrates - sucrose (10.5 wt.%) and milk protein (3.8 wt.%), as well as the presence polyglycerols and propylene glycol ethers - a total of 3.8 wt.%, making extra calories, which reduces the effectiveness of this emulsion, as a dietary product.

It is known that in the brand Olean-Olestra not only has liquid girasolereale with zero calories, as presented in the discussion part, but substitutes (DairyLean P, J, E), which contain a fraction of solid fat, which does not allow to obtain on the basis of their stable direct emulsion type oil/water.

The disadvantages also include the inability to use the entire line of substitutes with zero calories, including those in which high fractions of refractory solid fats increases the prospects of this brand as di the political product.

In U.S. patent No. 5516544, 4368213, 4705691, 6447824 number of traditional substitutes is preferably at least about 20.0 wt.% and most preferably at least about 75,0 wt.% by weight of the total oil in the emulsion.

The purpose of this invention is to provide means in the form of a concentrated emulsion-based Jerusalemites with zero calories, suitable for use as a raw material for biologically active food additives for use in the food industry and the quality of the product Wellness diet and clinical nutrition.

The technical result of the invention is the improvement of consumer characteristics, such as taste characteristics, in particular the aftertaste, which is expressed in disguise of osalennosti at high concentrations of synthetic Jerusalemites, coagulation and sedimentation stability during prolonged storage in the form of a concentrated emulsion with preservation of the sphericity of the particles Jerusalemites. As well as using the total number of substitutes, including products with high fractions of refractory solid fat, not giving the possibility of obtaining a stable emulsion with spherical particles.

To do this, as emulsifiers-stabilisers used hydrocolloids with value and emulsifying properties, that allows not only to increase the shelf life of the product under normal conditions, but additionally to improve therapeutic efficacy of a concentrated emulsion due to the surfactant properties of hydrocolloids, as well as to raise the concentration of Jerusalemites in the emulsion and to enter as fat phase full range of substitutes with zero calories.

The problem is solved as follows.

The proposed biologically active composition to control appetite and weight regulation, represents a concentrated emulsion containing girasolereale with zero calorie selected from the group of polyesters of sucrose, consisting mainly of a mixture of OCTA-, hepta - and Hexaemeron sucrose, triglycerides of Caprylic/capric fatty acid, liquid paraffin food, emulsifier-stabilizer selected from the group of: gum Arabic, saponins, modified starch, flavoring additive, preservative, vitamin a, beta-carotene and water in the following components in wt.%:

girasolereale with zero calories20,0-60,0
triglycerides of Caprylic/capric fatty acids0.01 to about 30.0
vaseline oil for food0.01 to about 30.0
emulsifier-stabilizerof 0.5 to 20.0
flavoring natural Supplement0,1-2,0
preservative0,05-0,5
vitamin a0,001-0,01
beta carotene0,001-0,01
waterthe rest of it.

The composition of Jerusalemites with zero calorie selected from the group of polyesters of sucrose, consisting mainly of a mixture of OCTA-, hepta - and Hexaemeron sucrose (product Information Olean, p.20 and Specification of products Olean, The Procter & Gamble With. Food ingredients, USA).

In this composition flavoring additive is selected from the group of natural concentrates produced by fermentation of various milk fat with the release of fatty acids (U.S. Patent No. 3653921, Technical information and specifications company ButterBuds. Food ingredients, USA).

The composition of a preservative selected from the group of potassium sorbate, sodium benzoate.

All food hydrocolloids new generation approved for use by the Committee of experts of the FAO/who as PI is of evich additives and are effective emulsifiers-stabilisers, enhanced coagulation and sedimentation stability of the concentrated emulsion system when the increase in the content of oil phase (Jerusalemites) up to 60 wt.%, as well as stability when diluted in a wide range of pH (from pH 3.0 to 8.0).

Concentrated form of emulsion (20-60 wt.%) allows you to reduce the dose a single dose of diet product, to improve its ability to sorbirovaniya bile acids as the active and inactive forms in the small intestine, and to stimulate the contraction of the walls of the large intestine, increasing therapeutic effectiveness of diet.

Introduction to the composition of preservatives in the range of 0.05-0.5 wt.%, (sorbic acid and its salts, sodium benzoate and other substances permitted for use by the Committee of experts of the FAO/who as food additives that prevent microbial and oxidative spoilage) provides increased shelf life of the drug up to 24 months at room temperature.

Flavoring concentrated natural supplements simultaneously solve two important tasks. Firstly, they improve the organoleptic properties of the composition, giving specific milky creamy taste of the product, and reduce unpleasant aftertaste, which is expressed in disguise of osalennosti when high is their concentrations Jerusalemites. Secondly, as on the chemical nature of fatty acids, they perform in the emulsion role of an additional emulsifier-stabilizer.

Introduction the formulation of vitamin a (retinol and/or in the form of provitamin beta-carotene) recommended by The Procter & Gamble With. for the correction of loss by the body of these vitamins during extended use in the dietary of these substitutes.

We offer a concentrated emulsion is prepared as follows.

Pre-prepared aqueous solution of the emulsifier-stabilizer preservative with water-soluble flavoring additive at a temperature not lower than 70-80°C. Then the resulting solution of the emulsifier slowly with vigorous ultrapremium (install the rotor/stator) at speeds from 3000 to 15000 rpm make a pre-prepared molten liquid oil phase containing oil OLEAN-OLESTRA, MCT oil, vaseline, cooking oil, vitamin a and oil soluble flavoring additive (70-80°C), was dispersed to obtain a homogeneous mass and after cooling the resulting homogeneous emulsion mass to a temperature of 30-40°C is added a pre-prepared solution beta-carotene and then re-dispersed in ultrameal for 5-10 minutes at a speed of not less than 3000-5000 rpm and/or optionally, homogeny irout at a pressure of 200 to 250 MPa 2-3 cycles on the high-pressure homogenizer.

The table below shows examples of various formulations of concentrated emulsions based Jerusalemites with zero calories.

Presented in table concentrated emulsion-based Jerusalemites with zero calories and emulsion-based composite compositions of substitutes oil (MCT oil and vaseline edible oil) have been used in the prevention AGP.

At long, 4-9 months, "soft" therapy CH preventive primarily for the management and control of appetite and weight management used the concentrated emulsion (20-55 wt.% Jerusalemites with zero calories) at a daily intake of no more than 30-50 g of the emulsion with an interval of 1-2 days.

Obtained preliminary data on the effect of the emulsion on the management and control appetite and weight control, as well as data on blood levels of cholesterol (LDL), triglycerides (TG), lipoprotein and high low-density (HDL and LDL) for a group of volunteers from 25 persons for a specified period up to 9 months show high functional activity developed concentrated emulsion at the desired operational mode of therapy CH.

It is noted that regardless of the time of admission (before or after a meal) and the concentration of Jerusalemites in emulsion (20-60 wt.%), after receiving a single dose of 20 g tako the emulsion is committed to sustainable long-term (up to 2-4 hours) loss of appetite. After 3-4 weeks of regular use emulsion duration of the lack of appetite is increased to 5-7 hours.

Monthly weight loss averaged 1.0 to 1.5 kg

The content of cholesterol in blood plasma decreased by 10-30%, triglyceride by 15-35%, LDL by 15-40%, and HDL increased by 5-15%.

Using the composition on the basis of a concentrated emulsion of Jerusalemites with zero calories as raw materials for the food industry for making it in the diet and dairy foods to reduce calorie primarily fat-containing products, including milk, sour cream, cream, mayonnaise, dairy products (yogurt, kefir), pastries, etc. it is necessary to consider the contents of Jerusalemites in concentrated emulsions and technological features of manufacture of these products.

The recommended level of introduction of the composition in the form of a concentrated emulsion in diet dairy products is 5 to 30 wt.%, that allows to reduce significantly the caloric content of these products and at the same time to solve the problem of control appetite and weight regulation in everyday products.

1. Biologically active composition to control what petiton and weight management characterized by the fact that it represents a concentrated emulsion containing girasolereale with zero calorie selected from the group of polyesters of sucrose, consisting mainly of a mixture of OCTA-, hepta - and Hexaemeron sucrose, triglycerides of Caprylic/capric fatty acid, liquid paraffin food, emulsifier-stabilizer selected from the group of: gum Arabic, saponins, modified starch, flavoring additive, preservative, vitamin a, beta-carotene and water in the following content, wt%:

girasolereale with zero calories20,0-60,0
triglycerides of Caprylic/capric fatty acids0.01 to about 30.0
vaseline oil for food0.01 to about 30.0
emulsifier-stabilizerof 0.5 to 20.0
flavoring natural Supplement0,1-2,0
preservative0,05-0,5
vitamin a0,001-0,01
beta carotene0,001-0,01
waterrest

2. The composition according to claim 1, where natural flavoring additive is selected from natural concentrates produced by fermentation of various milk fat with the release of fatty acids.

3. The composition according to claim 1, where the preservative is selected from the group of: potassium sorbate, sodium benzoate.



 

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