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  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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  • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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  • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
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  • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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  • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
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  • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

• the present invention relates to a particular composition and its use for the prevention of cardiometabolic risk.
• Cardiometabolic risk brings together several risk factors that can lead, in the more or less long term, to metabolic pathologies such as type 2 diabetes, and / or cardiovascular disease. These risk factors include increased blood glucose, dyslipidemia, high blood pressure, excess abdominal fat, family history, and tobacco.
• a patient at cardiometabolic risk must have at least three of these factors, some associations being more dangerous than others. It has been recognized in particular that associations where hyperglycemia is present, the risk is multiplied by two vis-à-vis other factors. We also know that the consequences are different depending on the factors involved:
• the main risks are: hyperglycemia, significant waist circumference, arterial hypertension, dyslipidemia, hypertriglyceridemia, visceral fat mass, chronic inflammation of low grade and insulin resistance;
• the main risks are: hyperglycemia, abnormal insulinemia, high HbAlc and / or HOMA IR, HOMA B and / or HOMA S abnormal homeostasis and too much weight;
• cardiovascular diseases the main risks are: hyperglycemia, arterial hypertension, dyslipidemia, heavy weight smoking and / or family history.
• the major factors in terms of morbidity and mortality are hyperglycemia, a large waistline involving a large visceral fat mass, hypertension, a low level of HDL cholesterol and a high level of triglycerides.
• the main cause is the presence of excessive visceral fat due to oxidative stress, which causes inflammation (measured in particular using the PAI-1 level, pro-thrombotic marker and secondarily by more general markers such as TNFa, IL6 or CRP us) and insulin resistance (determined by abnormal insulinaemia and / or evaluation of HOMA homeopathic IR, HOMA B and / or abnormal HOMA S models).
• the proposed drugs act on only one of the consequences of the metabolic syndrome such as hyperglycemia, hypertension, hypertriglyceridemia or hypercholesterolemia, but not on the whole of the metabolic syndrome.
• the poly pill proposed as prevention of cardiometabolic risk has been rejected by all the drug agencies.
• the objective of the present invention is to respond to this deficiency and to propose a composition capable of preventing the cardiometabolic risk and therefore the metabolic and / or cardiovascular pathologies resulting therefrom, by acting both:
• glycemia glycemia, waist circumference, blood pressure,
• the present invention aims at a particular composition suitable for oral administration, comprising at least one vegetable protein chosen from the pea protein, rice protein or a mixture of pea protein (s) and rice protein (s), and
• At least one protein of animal origin chosen from calcium caseinate, whey proteins, or a mixture, and / or
• At least one free amino acid selected from leucine, glutamine, isoleucine, valine, tryptophan or plant 5HTP, lysine, threonine, arginine and taurine, or a mixture of at least two of these amino acids, and / or
• At least one micronutrient chosen from vitamin D, vitamin B6, vitamin B9, vitamin E, calcium (preferentially milk calcium, that is calcium derived from the extraction of milk), magnesium (preferentially marine magnesium, ie magnesium extracted from seawater), zinc and chromium, or a mixture of at least two of these micronutrients, and / or
• At least one anti-inflammatory and / or antioxidant compound of vegetable origin chosen from the omega 3 fatty acid in the form of ALA, the purified EPA, the protectin in the form of PD1 or PDX, and curcumin, or a mixture of at least two of these anti-inflammatory compounds of plant origin.
• such a composition can be used as a health product, especially as a medical nutrition product, or food supplement, or food for the prevention of cardiometabolic risk, particularly for the prevention of metabolic and / or cardiovascular pathologies associated with cardiometabolic risk.
• the composition according to the invention may in particular be used to act on the vectors of the pathophysiology of visceral fat and on the clinical risk factors of cardiometabolic risk.
• the invention is particularly adapted to cardiometabolic risk for patients whose main risk factor is hyperglycemia.
• the invention therefore relates to a particular composition suitable for oral administration in humans comprising at least one vegetable protein chosen from pea proteins, rice proteins or a mixture of pea and protein protein (s) ( s) of rice, and:
• At least one protein of animal origin chosen from calcium caseinate, whey proteins, or a mixture, and optionally another animal protein, in particular a fish protein, and / or at least one free amino acid selected from leucine, glutamine, isoleucine, valine, tryptophan or plant 5HTP, lysine, threonine, arginine and taurine, or a mixture of at least two of these amino acids, and / or
• At least one micronutrient chosen from vitamin D, vitamin B6, vitamin B9, vitamin E, calcium (preferentially milk calcium, that is calcium derived from the extraction of milk), magnesium (preferentially marine magnesium, ie magnesium extracted from seawater), zinc and chromium, or a mixture of at least two of these micronutrients, and / or
• At least one anti-inflammatory and / or antioxidant compound of vegetable origin chosen from the omega 3 fatty acid in the form of ALA, the purified EPA, the protectin in the form of PD1 or PDX, and curcumin, or a mixture of at least two of these anti-inflammatory compounds of plant origin.
• composition according to the invention does not comprise other constituents apart from the excipients.
• composition therefore comprises at least vegetable proteins and one or more of the elements belonging to one of the following four groups:
• the composition therefore comprises at least one vegetable protein selected from pea proteins and rice proteins, or several pea proteins, or several rice proteins, or a mixture of one or more pea proteins and one or more rice protein.
• the vegetable proteins can be in native form (isolate or concentrate or mixture of isolate and concentrate) or in hydrolysed form (hydrolyzate).
• the vegetable protein or proteins are present in the form of an isolate or a concentrate.
• the degree of hydrolysis varies from 10 to 35%. Even more preferentially, the pea protein (s) are present as an isolate with a high level of viscosity to obtain a good solubility, this isolate must make it possible to obtain at least a level of 85% of pure proteins.
• the rice protein or proteins are preferentially present as a rice protein isolate with a level of at least 85% pure protein.
• the vegetable proteins used in the composition according to the invention have the advantage of acting on the level of the microbiota, the intestinal barrier, the adipose tissue and the adipocyte and they have a clinical impact on blood glucose and insulin resistance. , lipolysis and finally dyslipidemia and anti-thrombotic effect.
• composition may also comprise at least one animal protein selected from calcium caseinate and whey proteins or a mixture of at least two of these animal proteins.
• the animal proteins can be in native form (isolate or concentrate or mixture of isolate and concentrate) or in hydrolysed form (hydrolyzate).
• the composition comprises at least calcium caseinate.
• composition comprises whey proteins
• it preferably comprises whey in the form of an isolate, a concentrate and / or a hydrolyzate, or a-lactalbumin.
• the degree of hydrolysis preferably varies from 10 to 35%.
• the animal protein (s) of the composition according to the invention act on the AMPK and PPAR energy cycle, on the adipose tissue with lipolysis, the differentiation of pre-adipocytes and especially the cycle of the inflammation by infiltrated macrophages.
• the total amount of whole proteins (without taking into account the possible free amino acids added to the composition) present in a daily ration of the composition according to the invention for administration to humans orally is preferably between 15 and 50 g. , preferably divided into two takes.
• the proteins present in the composition according to the invention consist of amino acids participating in the effectiveness of the composition on the prevention of cardiometabolic risk, in particular:
• valine and glutamine which participate in the synthesis of proteins
• the protein or proteins of the composition according to the invention comprise at least the following amino acids: leucine, isoleucine, valine, glutamine, tryptophan, lysine, alanine, tyrosine, phenylalanine, threonine. Even more preferentially:
• leucine represents at least 7% of all the amino acids present in the protein (s) of the composition (percentage by weight relative to the total weight of the amino acids present in the protein (s) of the composition): this allows in particular to act on the 3HMGCoA indicator of ketogenesis,
• lysine and leucine together represent between 10 and 25% of the amino acids present in the protein (s) of the composition (percentage by weight relative to the total weight of the amino acids present in the or the proteins of the composition): this allows in particular to act on the acetyl Co A indicator of ketogenesis,
• the branched amino acids and glutamine together represent between 20 and 40% of the amino acids present in the protein (s) of the composition (percentage by weight relative to the total weight of the amino acids present in the proteins of the composition): this allows in particular to act on the muscle proteolysis,
• tyrosine and phenylalanine together represent between 7 and 10% of all the amino acids present in the protein (s) of the composition (percentage by weight relative to the total weight of the amino acids present in the or the proteins of the composition): this allows in particular to act on the 30H butyrate which is an indicator of ketogenesis and which also acts at the cerebral level, and / or the weight ratio of arginine to taurine is between 1.2 and 2.
• proteins present in the composition according to the invention preferentially act in the cycles of energy, ketogenesis and muscle proteolysis.
• composition according to the invention may also comprise free amino acids. These amino acids reinforce the action of whole proteins in the energy cycle, ketogenesis, muscle proteolysis and anti-inflammatory action.
• composition according to the invention may comprise a free amino acid selected from leucine, threonine, glutamine, isoleucine, valine, tryptophan or plant 5HTP, lysine, arginine and taurine, or a mixture of at least two of these amino acids.
• the composition comprises the following free amino acids: leucine, tryptophan or plant 5HTP, threonine, taurine and arginine.
• the total daily intake of leucine for a person with abdominal obesity should be between 3 and 5 g, in amino acids between 6.5 and 10.5 g, in tryptophan between 0.4 and 0.8 g, in neutral amino acids between 10 and 16 g and in threonine between 1 and 2.5 g; for the preservation of lean mass and maintenance of the energy cycle, the tryptophan, leucine and lysine amino acid group should be between 5 and 10 g.
• the objective of the present invention is to cover by the whole proteins and the free amino acids between 50 and 100% of the average quantity necessary for all these amino acids or groups of amino acids, knowing that these people have impairments. and that a larger intake during a limited period of 12 to 24 weeks is sometimes necessary to regulate the various cycles including those of energy.
• composition according to the invention may also comprise at least one micronutrient selected from vitamin D, vitamin B6, vitamin B9, vitamin E, milk calcium, marine magnesium, zinc and chromium or a mixture of at least two of these micronutrients. Preferably it includes all these micronutrients.
• composition also comprises at least one anti-inflammatory and / or antioxidant compound of vegetable origin chosen from omega 3 fatty acid in the form of ALA, ⁇ purified, protectin in PD1 or PDX form, and curcumin, or a mixture of at least two of these anti-inflammatory compounds of vegetable origin.
• at least one anti-inflammatory and / or antioxidant compound of vegetable origin chosen from omega 3 fatty acid in the form of ALA, ⁇ purified, protectin in PD1 or PDX form, and curcumin, or a mixture of at least two of these anti-inflammatory compounds of vegetable origin.
• it includes ALA and curcumin.
• ALA is the plant form of the omega 3 precursor of EPA whose essential action is anti-inflammatory especially on the endothelial wall.
• the composition may also contain purified EPA. This molecule allows for better protection at the level of the intestinal barrier to prevent LPS from passing this barrier.
• Curcumin has a local anti-inflammatory effect on the intestinal barrier which is also combined with that of the glutamine present in the composition.
• composition according to the invention can be obtained by a process as described below:
• a first mixture is obtained by mixing the constituents in the following order: vegetable proteins, animal proteins, free amino acids.
• the pH should be around 7 and stabilized at this level.
• a powder is thus obtained which can be converted into a tablet or liquid, or used in its powder form in sachets, sticks, cans or capsules, for example.
• composition according to the invention may be in any form suitable for oral administration. It may especially be in the form of powder or granules, ready-to-use beverages, bars or extrudates, the composition being supplemented with conventional excipients and fillers known to those skilled in the art.
• it is in the form of powder or granules packaged in a bag to be diluted in water.
• the various constituents of the composition act in synergy for an effect on the risk factors of the cardiometabolic risk.
• composition according to the invention can therefore be used as a health product, in particular as a medical nutrition product, dietary supplement or drug for the prevention of cardiometabolic risk, in particular for the prevention of metabolic and / or cardiovascular pathologies arising from cardiometabolic risk.
• medical nutrition product within the meaning of the invention is meant a particular health product, namely a food or therapeutic food supplement alone or in combination with other therapies.
• the composition according to the invention when it is administered orally in sufficient quantity, makes it possible to act directly on various risk factors for cardiometabolic risk, in particular:
• waist circumference o on clinical and biological risk factors: waist circumference, blood pressure, HDL cholesterol, LDL cholesterol, total cholesterol, triglycerides, blood glucose, and
• visceral fat inflammation (PAI 1) and insulin resistance (insulinemia, HOMA IR, OMA B and HOMA S).
• the invention therefore relates to the composition as described above for its use as a health product, medical nutrition product, food supplement or food, oral administration for the prevention of cardiometabolic risk in humans, in particular for the prevention and / or the treatment of metabolic and / or cardiovascular pathologies associated with cardiometabolic risk, in particular type 2 diabetes and cardiovascular diseases, atherosclerosis, ischemic coronary artery disease, stroke, AOMI, liver diseases such as steatosis, fibrosis, cirrhosis, metabolic infertility. These diseases are chronic, that is to say with a phase where the degradation is metabolic without visible manifestation but detectable by clinical and biological markers.
• cardiometabolic risk factors selected from: high blood pressure, high blood glucose, high triglycerides, low HDL cholesterol.
• hyperglycemic persons having an excessive waist circumference compared to IDF 2006 standards (80 cm for women and 94 cm for men), and at least one cardiometabolic risk factor chosen from: blood pressure high, high triglycerides, low HDL cholesterol.
• composition according to the invention can be used in particular to prevent and / or fight against pre-diabetes.
• the invention also specifically relates to the use of the composition for preventing and / or controlling at least one of the risk factors of cardiometabolic risk, in particular for reducing blood glucose, but also for reducing waist circumference, to normalize blood pressure.
• arterial to increase HDL cholesterol, to lower LDL cholesterol, to lower total cholesterol, to lower triglycerides, to reduce visceral fat, to reduce inflammation (especially to reduce PAI 1, adipocytokine pro thrombotic ) and to decrease insulin resistance (in particular to regulate insulinemia, HOMA IR, HOMA B and / or HOMA S).
• the invention can also be used to regulate the intestinal microbiota, in particular by increasing the bacteriodetes and decreasing the firmicutes.
• composition according to the invention is preferably between 60 and 120 g, preferably in two doses of 30 to 60 g distributed one in the morning at breakfast or at 11 am snack, and a snack in the afternoon.
• composition according to the invention should preferably be accompanied by a caloric restriction of between 500 and 800 kcal for a rest energy expenditure DER of about 1800 kcal.
• Example 1 The composition of Example 1 consists of: Quantity for Quantity
• Vitamin B6 1.4 mg 0.7 mg
• Vitamin B9 200 ⁇ g 100 ⁇ g
• amino acids present in the composition of the amino constituents of proteins and free amino acids are as follows: Quantity for a Quantity for a daily ration taken
• Example 2 The composition of Example 2 consists of:
• Vitamin B6 1.4 mg 0.7 mg
• Vitamin B9 200 ⁇ g 100 ⁇ g
• amino acids present in the composition are the following:
• Example 3 The composition of Example 3 consists of:
• Vitamin B6 1.4 mg 0.7 mg
• Vitamin B9 200 ⁇ g 100 ⁇ g
• amino acids present in the composition are the following:
• Example 4 The composition of Example 4 consists of:
• amino acids present in the composition of the amino constituents of proteins and free amino acids are as follows: Quantity for a Quantity for a daily ration taken
• Example 5 The composition of Example 5 consists of:
• Vitamin B6 1.4 mg 0.7 mg
• Vitamin B9 200 pg 100 pg
• amino acids present in the composition are the following:
• Example 6 The composition of Example 6 consists of:
• Vitamin B6 1.4 mg 0.7 mg
• Vitamin B9 200 ⁇ g 100 ⁇ g
• amino acids present in the composition are the following:
• Example 7 The composition of Example 7 is in the form of a powder containing 43 g of active molecules and excipients.
• the active molecules are as follows:
• amino acids present in the composition are as follows:
• composition according to the invention was the subject of a 12-week randomized, double-blind, international clinical trial in comparison with the product described in patent application FR2981544.
• qsp Xg of an element of the composition is meant the total amount of this element in the com position: amount provided by the proteins (calcium caseinate, whey isolate, whey concentrate, whey hydrolyzate) and supplemented by adding the element in free form to arrive at Xg.
• cardiometabolic risk factors selected from: high blood pressure, high blood glucose, high triglycerides, low HDL cholesterol.
• the patients followed a diet adapted to their eating habits, balanced (50% of carbohydrates, 35% of lipids, 15% of proteins, glycemic carbohydrates less than 10), low calorie (restriction of 600 kcal on Energy Expenditure Rest [ DER] calculated) and having two doses per day of a composition according to the invention (that of Example 7) bringing 380 kcal taken into account in the daily ration.
• Physical activity of at least 5000 steps was prescribed. This intensive phase was to be stopped after 12 weeks.
• This intensive phase was to be followed by a stabilization phase of 4 weeks comprising a balanced diet without restriction of calories and taking the composition according to the invention (that of Example 7) per day.
• composition according to the invention acts significantly (p ⁇ 0.0001) on visceral fat with a loss of 8.4% for the whole population and 9.3% for the subgroup of subjects with hyperglycemia.
• Total fat loss (p ⁇ 0.0001) was 6.6% for the total population and 7.7% for the subgroup, respectively, with a modest lean mass loss of 1.1%.
• ⁇ Insulinemia decrease of 10.1% for the total population and 15.7% for the subgroup
• ⁇ HOMA IR decrease of 12.6% for the total population and 19.2% for the subgroup
• Triglycerides (p ⁇ 0.0001) decreased by 16.9% for the total population and 19% for the subgroup
• the bactericidal closures ratio decreased by 13.7% for the total population and 15.6% for the subgroup.
• composition according to the invention therefore provides concrete and convincing results on subjects at cardiometabolic risk, particularly those in the most dangerous position with the presence of hyperglycemia which can be defined as a situation of pre-diabetes with cardiovascular risk.

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• 2014
  • 2014-10-22 FR FR1460157A patent/FR3027491B1/fr active Active
  • 2014-11-21 US US14/549,709 patent/US20160114002A1/en not_active Abandoned
• 2015
  • 2015-10-22 WO PCT/EP2015/074540 patent/WO2016062830A1/fr active Application Filing
  • 2015-10-22 EP EP15797865.1A patent/EP3209147A1/de not_active Withdrawn

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