FR2838645A1 - Reducing intracellular accumulation of lipids and treating obesity, by oral or local administration of synergistic combination of at least two vitamins and at least two minerals or trace elements - Google Patents

Abstract

Use of a synergistic composition (I) for reducing intracellular accumulation of lipids and treating obesity, where (I) comprises: (a) at least two vitamins selected from vitamins A, B2, B9 and E; and (b) at least two minerals or trace elements selected from magnesium, zinc, copper and selenium. Use of a synergistic composition (I) for reducing intracellular accumulation of lipids and treating obesity, where (I) comprises: (a) at least two vitamins selected from vitamins A, B2, B9 and E; and (b) at least two minerals or trace elements selected from magnesium, zinc, copper and selenium. In a variant (independent claimed) component (a) comprises at least two unspecified vitamins and component (b) comprises two unspecified minerals or trace elements. An Independent claim is also included for compositions containing combinations of (a) and (b) (optionally together with excipients) as pharmaceutical, cosmetic, dietetic or nutritional products.

Description

The present invention relates to the use of a synergistic composition

  based on vitamins, minerals and trace elements to stimulate the elimination of intracellular lipids. Vitamins, minerals and trace elements provide micronutrients essential for the metabolic function of the body. Vitamins produce organic substances with variable and sometimes complex chemical structures, while minerals and trace elements have

a mineral origin.

  These micronutrients each have a specific major role (constitutive, catalytic, coenzyme, prohormone) and none of them can be replaced by another for

  maintain homeostasis.

  The active doses are variable. Vitamins, for example active wind at low dose, the necessary proportions for each of them ranging from 1 to 25,000 if we take the extremes that wind respectively vitamin

  B12 for the weakest and vitamin C for the strongest.

  It is the same for trace elements.

  Values selected by different experts taking into account the scientific data concerning the nutritional needs, motivations and eating habits of the groups concerned (children, adolescents, adults, senior staff, sportsmen, etc.) were related to the establishment of Nutritional contributions Recommended (DUPIN H. ABRAHAM J. GIACHETTI I. Nutritional contributions advised for the French population, Tec & Doc Lavoisier, Paris, 1999) or to establish

  Recommended Daily Contributions (RDA).

  Despite the existence of these recommendations, a growing number of epidemiological studies carried out in developed countries tend to show the existence of more or less marked deficiencies depending on micronutrients and

population segment considered.

  According to the results of three main surveys conducted on the nutritional status of the French, the percentage of the population that does not receive the recommended contributions for different categories of micronutrients is as follows (SOUCCAR T. CURTAY JP The new guide of vitamins, Editions du Seuil , Paris, 1996, page 11): Vitamins, Percentage of Percentage of Average Minerals and Men Not Women Not Receiving Oligo-elements Not Receiving RDAs AJR Vitamin A 11.7 to 60 8 to 5032, 43 Vitamin B1 43 to 80 69 to 8068.00 Vitamin B2 27 to 60 24.6 to 6042.90 Vitamin B3 49.5 49,349.40 Vitamin B6 67.5 to 80 90 to 9282.38 Vitamin B9 40 to 90 50 to 9067.50 Vitamin C 25 a 60 15 to 6040.00 Vitamin D 90 to 98 90 to 98,694.15 Vitamin E 40 to 100 75 to 10078.75 Magnesium 60 8070.00 Calcium 20 30.025.00 Iron 5 55 to 9038.75 Zinc 80 9085.00 Total 59,56 These studies tend to show that overall, about 6 to 7 staff out of about 10 have a more or less complete deficiency with respect to less a vitamin, a mineral or a trace element but the exact consequences of these different deficiencies are not scientifically established. On the other hand, there is no food that contains all these vital elements in sufficient quantities and in

adequate proportion.

  The exact and complete role of vitamins, minerals and oligoelements remains unknown. The respective proportions between these different vital elements have never been scientifically established for

cellular function.

  To date, no correlation between vitamin, mineral, and trace element deficiencies and the problem of overweight or hypercholesterolemia has been reported.

scientifically established.

  In developed countries there is also a considerable increase in the proportion of individuals (about 40% of the population) with an overload.

  ponderale marke and excess weight.

  Weight overload results from the accumulation of large amounts of fat by certain cells of the body, the adipocytes. These cells can store large quantities of lipids inside their cytoplasm, which is the intracellular lipid. This excessive storage is actually related to the decrease in capacity

  elimination of waste and lipids by the cells.

  Many strategies have been proposed to reduce overweight, such as specific diets (hypocaloric, protein diet), consumption of plant extracts to "burn fat", drugs to reduce the feeling of hunger (isomerides ), hormonal treatments, medical care ... etc. These treatments result in physiological imbalances which can aggravate functional impairments, give temporary results, disrupt the normal physiology of the cells, cause harmful and toxic effects or induce a more commonly known rebound effect.

"Yo-Yo phenomena".

  Paradoxically, while the heart of the problem lies in the dysfunction of adipocyte metabolism, none of these rather general action strategies have been concerned with the very cause of overweight which is

  lipid accumulation at the intracellular level.

  There is no treatment that takes into account the decrease in the ability of cells to eliminate intracellular lipid deposits, whereas it is at this level that

  this is the real cause of overweight.

  The present invention relates to the use of a synergistic composition by vale vale or local vole based vitamins, minerals and trace elements to target the cell elimination capabilities in order to decrease the accumulation intracellular lipids without inducing toxicity or side effects. Thinning products for local application based on caffeine have the effect of mobilizing the fat reserves at the subcutaneous level but do not act on the accumulation of fat in the deep tissues. They have only a superficial action which does not make it possible to reduce the

overweight.

  Many dietetic or pharmaceutical compositions per vale vale use natural or synthetic products, extracts of plants known to act on overweight. These compositions combine, for example, the effect of diuretic, draining plant extracts that swell in the stomach and the digestive tract to reduce the sensation of hunger, but these compositions have no specific effect on the elimination of lipids. intracellular. The use of pharmacological active principles (caffeine, ephedrine, alpha and beta agonists) per vale vale in dietetic compositions

  or food is prohibited or restricted.

  Medication has a central mode of action (appetite suppressant)

  but have many side effects.

  Finally, there are many formulations on the market based on vitamins, minerals and trace elements. These products have either a broad and nonspecific action, or wind destined to a particular category of the population (children, adolescents, adults, women, seniors) but there is no synergistic composition based on vitamins, minerals and vitamins. micronutrients that are specifically intended to stimulate the intracellular lipid elimination capabilities to decrease

the weight without inducing toxicity.

  Now the applicant has discovered with astonishment that the excess weight can be reduced in a very short time without producing side effects by the use of synergistic compositions combining certain vitamins, certain minerals and trace elements that stimulate

  elimination of intracellular lipid pools.

  A synergistic composition of vitamins, minerals and trace elements that strongly stimulate and specifically the elimination of intracellular lipids has never been

described.

  An increase in intracellular lipid removal capabilities results in decreased fat storage, total body weight, and overweight. In addition, the effectiveness of these vitamin, mineral and trace element compositions can be further improved when combined with plant extracts known to act on pond overload by local or local routes or with a particular diet. The accumulation of intracellular lipids has been decreased in vitro by the use of synergistic compositions associating certain vitamins, certain minerals and trace elements, at doses of between 15 and 200 percent of the Recommended Daily Intakes (RDA), more particularly

50% of the A] Rs.

  The best results were obtained with specific combinations including 4 vitamins and 4 minerals or trace elements: vitamin A, vitamin B2, vitamin B9, vitamin E, magnesium, zinc, copper and selenium (decrease of

89% of intracellular lipids).

  The results of a 30-day clinical study in subjects with a body mass index greater than 20% of normal showed that the use of a synergistic composition containing at least two vitamins in the vitamin A, vitamin B2, vitamin B9, vitamin E, with at least two minerals or trace element among magnesium, zinc, copper or selenium allowed a mean decrease in body weight of -2.47 kg. The use of this composition is accompanied by a strong

  improvement of the parameters of appreciation of the index of

  be. The results on wind weight are better than when using a low calorie diet alone. The effectiveness of this synergistic composition of vitamins, minerals and trace elements is slightly improved when used in combination with a herbal dietary supplement known to act on overweight or other diets. In addition, the weight of the volunteers who used a synergistic composition associating vitamins, minerals and trace elements remained stable at the end of the trots mods of the period of observation which was not the case of the subjects using a low calorie diet senl. This observation shows that the use of a synergistic composition also makes it possible to stabilize the weight

  to prevent the rebound effect observed at the end of a diet.

  This is why the subject of the present application is the use of synergistic compositions containing vitamins, minerals and trace elements which make it possible to stimulate the elimination capacities of intracellular lipids in order to reduce ponderal overload, in combination or not with compositions containing plants known to act on overweight, with a particular diet, exercise machine

of muscle electrostimulation.

  The vitamins, minerals and trace elements used in the constitution of these compositions can come from different origins for beings as are under different galenic forms whose modes of preparation

wind familiar to the man of art.

  In the present application and in what follows, the term "composition" according to the invention is intended to mean the preparations

  solid rather than solid (liquid, semi-liquid, viscous).

  Under preferential conditions of implementation of the invention, the compositions wind pharmaceutical or dietetic preparations for use by vale vale. Under preferential conditions of implementation of the invention, such a solid composition can thus be in the form of lyophilized powder or not, instantaneisee (soup), in extruded form (granules, filaments, pasta), in the form of sachets, gelules, tablets. Under preferential conditions of implementation of the invention, such a non-solid composition can thus be in the form of a solution that can be purchased or diluted,

strop or ampoules single dose.

  Under preferential conditions of implementation of the invention, the compositions wind pharmaceutical or cosmetic preparations for use by local flies. According to an advantageous embodiment, these galenic forms have pharmaceutical compositions with immediate or prolonged release allowing administration by steal.

  local (cream, gel, transdermal system).

  According to an advantageous embodiment, the composition that makes it possible to stimulate the elimination capacities of intracellular lipids results from the use of agents that make available to the body vitamins and minerals.

and trace elements.

  Under preferential conditions of implementation the agents allowing a vitamin intake may be selected from the usual synthetic or natural intake forms of vitamins, a source or extract rich in vitamins. Under preferential conditions of implementation agents allowing a contribution of minerals and trace elements may be selected from the forms of intake

  synthetic or natural uses of minerals and oligo-

  elements, a source or extract rich in minerals or oligo-

  elements, yeasts enriched with minerals or trace elements.

  Such agents wind for example marketed by the company QUIMDIS (France) or by the company COOPER (Cooperation

French Pharmaceutical, France).

  The usual dose, which varies according to the composition chosen, may for example be administered daily for a period of at least 14 days, preferably 30 days, at doses of between 15 and 200 percent of the recommended daily intake (RDA) of each. of these

  elements, especially 50% of RDAs.

  AJR means the amount of micronutrient actually available for use by the body

  and not the gross weight of the input form used.

  Under preferential conditions of implementation, this composition is used to accelerate the elimination of intracellular lipids, cellular detoxification in order to reduce weight, act on lobesite, stress, fatigue, improve physical fitness, sleep, unrest

age or sexual desire.

  Depending on the problem, these compositions may be associated with a medicament, a food or a low-calorie diet, a nutritional or cosmetic product for

achieve synergistic effects.

  Therefore, the subject of the present invention is also the combination of synergistic compositions for stimulating intracellular lipid removal capabilities with compositions containing known plants or agents.

  to act on overweight.

  Under preferential conditions of implementation of the invention, different active ingredients are used,

especially plant extracts.

  By "plant extract" is meant plants which parts of plants, for example and preferably whole plant and preferably dried or dehydrated, and crushed, or extracts of such plants or parts of plants obtained with at least one aqueous and / or organic solvent and in a conventionally

  employee in pharmacy or dietetic, liquid or solid.

  Under preferential conditions of implementation, plant extracts and agents known to act on overweight are chosen from the group of plant extracts naturally containing thermogenesis-stimulating active ingredients, or containing cholagogue and choleretic substances, agents able to retain fat at

  intestinal level or stimulate intestinal transit.

  Thus, one can find in the compositions according to the invention, one or more substances capable of stimulating thermogenesis, and in particular, caffeine or a plant extract rich in caffeine obtained for example from seeds of Guarana (Paullinia cupana). , an extract of The Green (Thea sinensis), an extract of Cola nut (Cola nitida), choleretic substances and cholagogues, preferably cynarin or an extract of Artichoke (Cynara scolymus), certain herbs, preferably the Ginger (Zingiber officinalis), enzymes, preferably bromelaine or an extract of Pineapple (Ananas comosus) rich in bromelaine, papain or papaya extract (Carica papaya) rich in papain, plant fibers, especially fruits (lemon, grapefruit, apple), cereals, pectins, fructo-oligosaccharides, preferably inulin, chitosan, clay, preferably a clay pour illite type with a phyllitous structure, a montmorrillo clay nite,

  kaolinite, attapulgite, sepiolite, smectite and bentonite.

  Such active ingredients or plant extracts are sold for example by the company BIOSPHERE (France) or the company GREENTECH (France) or by the company

  COOPER (French Pharmaccutique Cooperation, France).

  These combinations can therefore be in the form of lyophilized powder or not, in extruded form (granules, filaments, pasta), in the form of sachets, capsules, tablets. These combinations can also be in the form of a pharmaceutical or cosmetic preparation by steal

  local, cream, gel, transdermal system.

  The subject of the present invention is also the combination of compositions capable of stimulating the intracellular lipid elimination capacities with a particular diet, an exercise machine or

of muscle electrostimulation.

  In preferential conditions of implementation the particular diets may be chosen from the group of low calorie diets, diets

  hyperproteins, diets that improve intestinal transit.

  Under preferential conditions of implementation, exercise machines or electrostimulation devices may be devices or devices to work the muscles to increase the expense

energy of the organism.

  The following examples illustrate this request. These examples of compositions for stimulating intracellular lipid elimination capabilities have been developed on the basis of results obtained in pharmacological studies. Some compositions then

  have been subjected to clinical trials.

EXAMPLE 1

  Pellets, tablets and sachets of vitamins, minerals and dioligo-elements were prepared according to the formula: (in milligrams per capsule, tablet or sachet) Vitamin A (beta carotene) 24.0000 Vitamin B2 (riboflavin) 0.8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Selenium (sodium selenate) 0.0822 Excipient for gels qs 330 mg Excipient for tablets qs 400 mg Excipient for sachets qs 1400 mg Dosage: 1 gel or 1 tablet each morning with a glass of water or 1 sachet that can be mixed with a yogurt

or any other food.

EXAMPLE 2

  Vitamin, mineral and trace element capsules associated with plant extracts have been prepared according to the formula: milligrams / gel Vitamin A (beta carotene) 24.0000 Vitamin B2 (riboflavin) 0.8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Selenium (sodium selenate) 0.0822 Guarana extract with 25% natural caffeine25 .0000 Artichoke extract with 1% cynarin 10.0000 Excipients qs 365 mg

  Dosage: 1 gel each morning with a glass of water.

EXAMPLE 3

  Vitamin, mineral and trace element tablets associated with extracts of plants corresponding to the formula: milligrams / tablet Vitamin A (beta carotene) 24.0000 Vitamin B2 (riboflavin) 0 were prepared. 8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Selenium (sodium selenate) 0. 0822 Kola nut extract with 25% caffeine20.0000 Pineapple extract10. 0000 Grapefruit Fiber10.0000 Excipients qs 400 mg Dosage: 2 tablets each morning with a glass of water.

EXAMPLE 4

  Packets of vitamins, minerals and trace elements associated with plants or agents known to act on the overweight weight answer formula: milligrams / sachet Vitamin A (beta carotene) 24.0000 Vitamin B2 (riboflavin) 0.8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Sodium selenium tselenate 0.0822 Inulin of chicoree100 . 2160 Guarana extract with 25% natural caffeine25.0000 Artichoke extract with 1% cynarin10.0000 Green tea extract with 3% natural caffeine10.0000 Clay poured50.0000 Poube of pineapple juice10.0000 Tamarin7.0000 Ginger7. 0000 Eraser Karaya6.0000 Excipients qs 1400 mg Dosage: 1 sachet per ou with a glass of water or

  mixed with a yogurt, preferably in the morning.

EXAMPLE 5

  Vitamin, mineral and micronutrient capsules were prepared according to the formula: milligrams / gel Vitamin A (beta carotene) 8.0000 Vitamin B1 (thiamine hydrochloride) 0.2350 Vitamin B2 (riboflavin) 0.2670 Vitamin B3 (nicotinamide) 3.0000 Vitamin B5 (Pantothenic Acid) 1.0000 Vitamin B6 (Pyridoxine Hydrochloride) 0.3350 Vitamin B8 (Biotin) 0.0250 Vitamin B9 (Folic Acid) 0.0350 Vitamin B12 (Cyanocobalamin) 0.000165 Vitamin C (Ascorbic Acid) 20.0000 Vitamin E (508 Vitamin Powder E) 3.3350 Magnesium (magnesium oxide) 83.0000 Calcium (calcium carbonate) 333.2000 Iron (iron gluconate) 18.6400 Iodine (potassium iodide) 0.0327 Potassium (potassium chloride) 24.4900 Zinc (zinc oxide) 3.1120 Copper (copper oxide) ) 0. 4170 Selenium (sodium selenate) 0.0274 Excipients qs 540 mg Dosage: 3 capsules per day with a glass of water, the

morning preferably.

EXAMPLE 6

  Pasta containing a combination of vitamins, minerals and trace elements has been prepared according to the formula: Milligrams per 100 grams of pasta Vitamin A (beta carotene) 24,000 Vitamin B2 (riboflavin) 0.8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Selenium (sodium selenate) 0.0822 fresh eggs 32 000.0000 Durum wheat meal qs 100 grams Dosage: 100 to 200 grams of pasta per day cooked a

the water.

EXAMPLE 7

  Combination of the synergistic composition of Example 1 with 10 g in 15 centilitres of dehydrated soup water based on cabbages, vegetables and proteins of dairy origin to consume at will. This preparation for a reduced calorie diet low in carbohydrates and lipids, enriched in protein and dietary fiber brings about 32

  kilocalories for 10 grams of dehydrated soup.

EXAMPLE 8

  Combination of the synergistic composition of Example 1 with 100 grams of fortified protein-enriched pasta

  lunch and dinner and green vegetables will.

EXAMPLE g

  Combination of the synergistic composition of Example 1 with sachets of 14 g each, based on plants known to act on the overweight corresponding to the formula: Percentage weight Inulin of chicoree 82,555 Soga precursor 2,500 Germ of wheat 1,675 Extract artichoke with 3% cynarin 0.950 Guarana extract with 10% caffeine 0.570 Green tea extract with 3% caffeine 0.570 Oat precooked 0.250 Apple fiber O.lOO Lithothamne O.lOO Yeasts 0.025 Aroma 0 095 Excipients qs 100% Dosage: 1 sachet per day with a glass of water or

  mixed with a yogurt, preferably in the morning.

EXAMPLE 10

  Combination of the synergistic composition of Example 1 with a slimming gel corresponding to the formula: Weight percent Caffeine 2.0 Centella asiatica 2.0 extract Mimosa tenuiflora extract 1.5 Azadirachta indica extract 0.6 Garcinia cambogia extract 5.5 Excipients qs 100% Dosage: apply a nut of product morning and evening and

  to penetrate by a light massage.

EXAMPLE 11

  A 10 cm 2 transdermal system was prepared to provide each day the vitamins, minerals, and trace minerals indicated and corresponding to the formula: milligrams / day Vitamin A (beta carotene) 24,000 Vitamin B2 (riboflavin) 0.8000 Vitamin B9 (folic acid) 0.1000 Vitamin E (powder with 50% vitamin E) 10.0000 Magnesium (magnesium oxide) 248.7000 Zinc (zinc oxide) 9.3350 Copper (copper oxide) 1.2520 Selenium (sodium selenate) ) 0.0822 Excipients and transdermal adhesive system qs 500 mg

EXAMPLE 12

  Combination of the composition of Example 11 with a 10 cm 2 transdermal system making it possible to supply each day to the body the indicated amounts of agents known to act on overweight and plant extracts corresponding to the formula: milligrams / day Caffeine 10.0 Guarana extract 20.0 Extract of Fucus 10.0 Excipients and transdermal adhesive system qs 500 mg The present invention further relates to a process for the preparation of the compositions described above, characterized in that it is mixed, according to methods known per se, the active ingredient (s) with acceptable excipients or solvents, in particular pharmaceutically or cosmetically

  acceptable or acceptable in the diet.

TOLERANCE STUDIES:

  Acute rat toxicity studies carried out in accordance with OECD Guidelines No. 401 under quality assurance conditions show that the preparations used in the study are presented as a non-toxic example.

dose of 5 g / kg.

  Local cutaneous tolerance and ocular tolerance studies in rabbits performed according to the official method for the assessment of cutaneous superficial aggression (Order of 11 May 1993) and the official method for the evaluation of ocular irritation (Order of June 9, 1992) under quality assurance show that the preparations used by the local community presented as an example

non-irritating wind.

  PHARMACOLOGICAL STUDY: Investigation of agent associations capable of stimulating cell elimination capabilities

  to decrease the accumulation of intracellular lipids.

  To evaluate the effect of vitamins, minerals and trace elements on the ability of cells to remove intracellular lipid deposits, in vitro cultures of smooth muscle cells were prepared on plastic slides 1 cm in diameter according to the method described by Shrivastava et al. (Mesh, Pharmacol., Clinical Exp., 15, 345-350, 1993.). A monolayer culture at 50% confluence was obtained in 4 days. The rabbit hyperlipidemic serum was added to the culture medium, the cells were incubated at 37 ° C and 5% CO2 for 48 hours and the intracytoplasmic lipid deposits were quantified. The culture medium was then replaced by a white medium predefined at 1% fetal calf serum but not

  containing no vitamins, minerals and trace elements.

  The desired concentrations of vitamins, minerals and trace elements were prepared in the pre-defined white medium by dissolving the substances tested in the medium and replacing the original culture medium with the medium.

containing the products to be tested.

  The cytotoxicity of each vitamin, mineral or oligo-

  element has been previously determined. None of the concentrations used was cytotoxic. The concentration of product tested represented 1/100 of the daily contributions

  Recommends (RDA) per milliliter of culture medium.

  The tested products were: vitamin A (beta carotene), vitamin B1 (thiamine hydrochloride), vitamin B2 (ribeflavine), vitamin B3 or PP (nicotinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine hydrochloride) , Vitamin B8 or vitamin B9 (folic acid), vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin E (tocopherol acetate), iron (iron gluconate), lode (potassium iodide), potassium ( potassium chloride), zinc (zinc oxide), copper (copper oxide), magnesium (magnesium oxide), calcium (calcium gluconate), selenium (sodium selenate). Only items that showed some activity during the preliminary selection stage were selected for

following experiences.

  Intracellular lipid deposits were evaluated 3 days after exposure to the products tested according to the

  method described by Shrivastava et al. (Mesh, Find, Exp.

  Clin. Pharmacol., 15, 345-350, 1988). The results were expressed as a percentage of average decrease in intracellular lipid stores relative to untreated control cultures considered to contain 100% lipid deposition. The following results were obtained with the products tested alone (Table 1), with the associations of two products (Table 2) and with the associations

  synergistic effects of several micronutrients (Table 3).

  Table 1 Percent decrease in intracellular lipid deposits with test products alone (n = 24). Element Concentration Percentage of Testee in μg / ml decrease (0.016% of RDA) of intracellular lipids Vitamin A 8.0 12.6 + 2.3 Vitamin B1 0.23 7.7 + 1.4 Vitamin B2 0.26 14, 5 + 3.9 Vitamin B3 3.0 2.5 + 1.0 Vitamin B5 1.0 4.5 + 2.1 Vitamin B6 0.335 9.9 + 2.9 Vitamin B8 0.025 1, 8 + 0.7 Vitamin B9 0.035 17.5 + 4.6 Vitamin B12 0.0001 8.2 + 2.5 Vitamin C 20.0 11.2 + 4.1 Vitamin E 3.33 21.4 + 3.9 Magnesium 66.67 22 , 0 + 5.2 Calcium 178.0 0 Iron 18.64 6.3 +2.7 Iodine 0.03 0 Potassium 24.49 0 Zinc 3.11 16.3 + 4.4 Copper 0.42 24.3 + 6.2 Selenium 0.013 24.4 + 5.3 These results show that the products tested alone have no effect on the decrease in the accumulation of intracellular lipid waste except for vitamin A, vitamin B2, vitamin B9, vitamin E, magnesium,

zinc, copper and selenium.

  Table 2: Percentage decrease in intracellular lipid deposits with combinations of two products (n = 24) Percent decrease in intracellular lipids Vitamin A + vitamin B2 20.2 + 4.6 Vitamin A + vitamin B9 26.3 + 5 , 5 Vitamin A + Vitamin E 29.2 + 6.7 Vitamin A + Magnesium 26.1 + 4.4 Vitamin A + Zinc 18.3 + 4.4 Vitamin A + Copper 21.3 + 9.1 Vitamin A + selenium 17.2 + 6.1 Vitamin B2 + vitamin B9 18.3 _ 2.7 Vitamin B2 + vitamin E 20.0 + 4.1 Vitamin B2 + magnesium 30.2 + 8.1 Vitamin B2 + zinc 21.1 6.6 Vitamin B2 + copper 23.3 + 7.3 Vitamin B9 + vitamin E 24.4 + 6.6 Vitamin B9 + magnesium 18.1 + 8.2 Vitamin B9 + zinc 18.4 + 3.2 Vitamin B9 + copper 22.6 _ 4.9 Vitamin E + magnesium 25.9 _ 4.9 Vitamin E + zinc 26.6 + 7.6 Vitamin E + copper 17.7 _ 2.7 Zinc + copper 16.6 + 4 , 9 Zinc + magnesium 21.9 + 7.2 Copper + magnesium 24.6 + 6.2 Vitamin B2 + selenium 24.6 + 2.7 Vitamin E + selenium 22.2 + 7.8 Magnesium + selenium 23.7 + 8.2 These results They show that the combination of two vitamins, minerals or trace elements does not improve the elimination of intracellular lipids. The activity is not additive. The activity of the combination of magnesium and vitamin B2 is greater than that of the two elements taken separately. Table 3: Percentage decrease in intracellular lipid deposits with synergistic combinations of several micronutrients (n = 24) possibly in combination with plant extracts. (vitamin A = A, vitamin B2 = B2 and so on for vitamins, the international symbols of the periodic table of elements

  designates the corresponding minerals and trace elements).

  Percentage of decrease in intracellular lipids

A + B2 + B9 + E 26.4 + 6.9

A + B2 + Mg + Zn 70.0 + g.3

A + B5 + B6 + B8 22.4 7.6

  A + Fe + I + K 15.3 + 4.3 B9 + Fe + Mg + Zn 31.2 + 8.4 A + B2 + Cu + Se 68. 4 + 8.8 A + B2 + Mg + Se 81.2 + 11.4 B5 + B6 + Cu + Se cytotoxic B2 + B9 + Mg + Zn 68.8 + 11.4 B2 + B9 + Zn + Se 77.3 + 9.9 B2 + B9 + Mg + Se 76. 3 + 13.2 B2 + B9 + Cu + Se 80.4 + 8.2 B2 + Mg + Cu + Se 34.9 + 6.7 B5 + B6 + B8 + Fe + 24.6 + 7.2 A + B2 + Mg + Cu 76.3 + 14.6 B2 + B9 + E + Zn 42.6 + 14.6 D + E + Zn + If 52.0 _ 9.0 E + Ca + Fe + Cr 36.4 + 8.8 A + B2 + B9 + E + Mg + Zn + Cu + Se 89.2 + 12.6 A + B2 + B9 + Mg + Zn + Cu + Se 72.1 + 11.6 B2 + B9 + E + Mg + Zn + Cu + Se 81.6 + 12.0 A + E + Mg + Zn + Cu + Se 71.6 + 9.9 A + E + Zn + Cu + Se 61.4 + 13.0 E + Mg + Zn + Cu + Se 40.1 + 8.8 A + B2 + Mg + Cu + caffeine (0.01%) 84.4 _ 14.6 A + B2 + Mg + Cu + Soy Phytoestrogens (10%) 83.4 _ 17.3 The results show that in order to eliminate intracellular lipids, it is essential to combine at least two vitamins among vitamin A and vitamin B2. vitamin B9 and at least two minerals or trace elements among magnesium, zinc, copper and selenium. The

  best wind results obtained by combining these 8 elements.

  Activity decreases in the absence of any of these elements.

  CLINICAL STUDY: Confirmation of results in humans Gelules, tablets and sachets containing% RDA in vitamin A, B2, B9, E, magnesium, zinc, copper and selenium were prepared (gel or tablet).

  or the sachet per day according to the form used).

  Adult male volunteers (approximately%) or female volunteers (approximately 65%) with a body mass index of 20% above normal were selected to evaluate the effect of different diets on body weight period of 30 days. The weight of the volunteers was also evaluated 3 mods after the date of

beginning of the study.

  The decrease in body weight was related to the enhancement of cellular metabolic functions which facilitates the removal of intracellular lipids and wastes from the body. The effect on different wellbeing parameters was evaluated using scales of scores ranging from 0 to 4. Five groups studied under identical conditions were formed for the study conducted by a research institute accredited by the Ministry of Health.

Research.

  Group 1: dietary supplement of vitamins,

  minerals and trace elements according to Example 1.

  Group 2: combination of a dietary supplement of vitamins, minerals and trace elements associated with a

  Herbal dietary supplement according to Example 9.

  oroupe 3: combination of a dietary supplement of vitamins, minerals and trace elements associated with a diet containing green vegetables at will, fruits and grams of pasta hyperproteines to consume noon and evening

according to Example 8.

  Group 4: diet based on freeze-dried vegetable soup as an instant preparation to mix with boiling water. Group 5: combination of a dietary supplement of vitamins, minerals and trace elements associated with a diet of freeze-dried vegetable soup in the form of instant preparation to be mixed with boiling water

according to example 7.

  The following average results were obtained: Number of Weight Loss Average Volunteer Index in Well-Being Days (1 to 4) HF H Female Group 1: 830 -2.22 -2.61-2.47 3.21 Group 2: 918 -3.67 -3. 82-3.76 3.42 Group 3: 412 -2.10 -2.93-2.62 3.11 Group 4: 714 -1.15 -1. 30-1.22 1.80 Group 5: 1218 -2.20 -2.75-2.56 2.89 These results show that the combination of 50% of the RDAs in vitamin A, vitamin B2, vitamin B9, vitamin E, magnesium, zinc, copper and selenium, decreases the weight in men and women (average of -2.47 kg in 30 days) by accelerating the elimination of intracellular lipids. An improvement in the results is obtained when the synergistic composition is combined with a herbal dietary supplement. These results can also be improved in combination with other diets, but the additional weight reduction obtained is not significant, showing that most of the observed weight loss is due to the synergistic composition of vitamins ( A, B2, B9, E), minerals

  and trace elements (magnesium, zinc, copper, selenium).

  Group 4 volunteers receiving only a diet of vegetable soup showed a decrease in weight much lower than the groups receiving the composition

  synergistic of vitamins, minerals and trace elements.

  Moreover, the weight of the volunteers who used a synergistic composition associating vitamins, minerals and trace elements remained stable at the end of the trots mods of the period of observation which was not the case of the subjects using a low calorie diet senl. This observation shows that the use of a synergistic composition also makes it possible to stabilize the weight in order to

  prevent the rebound effect observed at the end of a diet.

  In the subjects studied, the index of well - being was strongly increased with the synergistic composition of vitamins, minerals and oligoelements which remarkably improved the parameters of stress, sleep, physical fitness and fatigue which shows that the synergistic composition of vitamin A, vitamin B2, vitamin B9, vitamin E, magnesium, zinc, copper and selenium

  has a positive effect on health in general.

Claims (9)

CLAIM I CAT I ONS   1. Use of a synergistic composition per vale vale to decrease the accumulation of intracellular lipids characterized in that it comprises at least two vitamins selected from vitamin A, vitamin B2, vitamin B9, vitamin E with at least two minerals or trace elements selected from magnesium, zinc, copper and selenium to treat overweight. 2. Use of a synergistic composition per vale vale to reduce the accumulation of intracellular lipids characterized in that it comprises at least two vitamins with two minerals or trace elements for to deal with overweight.   3. Use of a synergistic composition according to   claims 1 to 2 characterized in that it is used by local flight.   4. Use of synergistic composition according to   Claims 1 to 3 in combination with a composition   by vole based on agents that stimulate thermogenesis, have a cholagogue or choleretic effect or   which are known to reduce overweight.   5. Use of a synergistic composition according to claims 1 to 3 in combination with a diet low calorie, hyperprotein or stimulating the intestinal transit.   6. Use of a synergistic composition according to   Claims 1 to 3 in combination with apparatus   exercise or muscle stimulation device. 7. A combination of compositions as defined in   one of claims 1 to 6 as a product   pharmaceutical, cosmetic, dietetic or nutritional.   8. A combination of compositions as defined in   one of claims 1 to 6 and an excipient   pharmaceutically or cosmetically acceptable.   9. A combination of beautiful compositions that defined   one of claims 1 to 6 and an acceptable excipient