WO2023021259A1

WO2023021259A1 - Composition for ketogenic diet and method for preparing same

Info

Publication number: WO2023021259A1
Application number: PCT/FR2022/051583
Authority: WO
Inventors: Sybille BELLAMY
Original assignee: Ketom Plus
Priority date: 2021-08-16
Filing date: 2022-08-16
Publication date: 2023-02-23
Also published as: FR3126097A1

Abstract

Orally administrable composition for a ketogenic diet, comprising a mass proportion of lipids of between 70 and 92%, including 30 to 65% of medium-chain triglycerides, known as MCTs (C6 to C12 fatty acid triglycerides), and from 5 to 15% of taurine, preferably between 7 and 12% of taurine, and a thickener chosen from an edible wax with a melting point of between 55 and 85°C. The composition for a ketogenic diet is prepared according to the method comprising mixing said edible wax and the MCT triglycerides, with stirring, at a temperature at which the edible wax is liquid, adding taurine, then, after cooling, introducing the other ingredients, still with stirring, in order to obtain said composition capable of thickening while standing at ambient temperature and of returning to a fluid appearance with stirring, while at the same time preserving the homogeneity thereof.

Description

Title of the invention: Composition for ketogenic diet and process for its preparation

[0001] FIELD OF THE INVENTION

The present invention relates to the field of ketogenic diets and more particularly to a composition for a ketogenic diet and its method of preparation.

[0003] The ketogenic diet consists of promoting, in the diet, a very high consumption of lipids by considerably reducing the proportion of carbohydrates, without modifying the protein intake. Lipid intake, mainly fatty acids, can reach 70 to 90% of the daily calorie intake, while carbohydrate intake can be reduced to 50 g per day, or even 20 g per day. Since the glucose reserves in the body are then insufficient, the main energy substrate is provided by the degradation of fatty acids into ketone bodies; hence the name ketosis phenomenon.

[0004] PRIOR ART

[0005] It has been known for many years that such a ketogenic diet could have anti-convulsant effects in epileptics and make severe drug-resistant epilepsies disappear, or even could relieve people suffering from serious side effects due to allopathic treatments.

[0006] Various patents have more recently proposed food compositions not only useful for the treatment of epilepsy, but also in the event of diabetes, tumours, cognitive impairment, autism, obesity, spinal cord injuries, Alzheimer's disease, or Parkinson's.

[0007] In this context, document CN111280442A describes a biscuit comprising the following mass proportions: 44-78 parts of lipids, 10-21 parts of proteins, 4.5-45.5 parts of carbohydrates and 3-19 parts of fibers water-soluble foods, lipids being composed of 30-50% medium-chain fatty acids and 50-70% long-chain fatty acids. These cookies also contain small proportions (less than 0.4 parts by mass) of taurine, carnitine, DHA and vitamins. This preparation is solid and is not suitable for certain types of patients, for example, people who are prone to slipping.

[0008] In parallel, several studies have shown that taurine supplementation protects against diseases associated with mitochondrial defects, such as mitochondrial diseases, metabolic syndrome, cancer, cardiovascular diseases and neurological disorders (Jong et al, “ The Role of Taurine in Mitochondria Health: More Than Just an Antioxidant". Molecules. 2021 Aug 13;26(16):4913; Ohsawa Y. et Al., "Taurine supplementation for prevention of stroke-like episodes in MELAS: A multicentre , open-label, 52-week phase III trial". J. Neurol. Neurosurg. Psychiatry. 2019;90:529-536).

[0009] Compositions for ketogenic diet intended for the treatment of patients undergoing chemo- or radiotherapy are also known: lipids, proteins and carbohydrates in a lipid/carbohydrate+protein weight ratio of 4/1, the lipids containing at least 25% medium-chain triglycerides. This composition does not contain taurine.

[0010] Document US2016/175378A1 discloses a composition for a ketogenic diet intended for seriously ill patients for enteral or parenteral administration. In this composition the lipids are rich in omega-3 or are medium chain triglycerides (abbreviated MCT). This nutritional composition includes 50% lipids and 50% proteins, in fact in the form of a mixture of essential and non-essential amino acids.

[0011] AIMS OF THE INVENTION

A first object of the present invention is to provide a composition for a ketone diet that can be administered orally, for any type of patient, without risk of going the wrong way, that is to say for example using a spoon. .

Another object of the invention is to propose a composition for a ketone diet which can be administered orally, with an improved taste aspect, in particular which can be administered to children. Another object of the invention is to provide a composition for a ketone diet that can easily be incorporated into foods during meals.

Another object of the invention is to provide a composition for a ketone diet that can be administered orally, containing a higher taurine content than the compositions of the prior art, the composition remaining stable and homogeneous over time. This stability of the composition is necessary, both to enter an industrial preparation process, and for the end user.

[0016] DESCRIPTION OF THE INVENTION

[0017] To this end, the present invention provides a composition for a ketogenic diet, which can be administered orally, comprising a mass proportion of lipids of between 70 and 92%, including 30 to 65% of medium-chain triglycerides called TCM (acid triglycerides fat C to C12), and 5 to 15% taurine, preferably between 7 and 12% taurine.

[0018] Taurine has neurotransmission properties (Md. Jakaria et al., Redox Biology, 2019) and is involved in cardiac and muscular functions (Yan-Jun Xu et al. Exp Clin Cardio Vol13 N°2, 2008). It is also involved in the mechanism of lipid digestion. The combination of lipids and taurine in the same composition is therefore quite interesting.

[0019] The use of MCT triglycerides has also surprisingly made it possible to incorporate levels of taurine hitherto never achieved in an oily composition, in particular for oral administration.

[0020] Preferably, the MCT triglycerides comprise coconut oils, preferably a mixture of virgin oil and refined oil, in proportions of 40 to 50% by weight of the composition. The presence of these coconut oils in two different forms significantly improves the taste of the composition. Virgin coconut oil is rich in triglycerides of essential fatty acids, including lauric, palmitic, myristic, caprylic, and capric acids. In addition, it contains vitamins E, A, B3, B5 and B6.

The composition according to the invention may also comprise hemp seed oil, preferably in proportions of 20 to 25% by weight of the composition. Hemp oil is indeed rich in essential fatty acids omega 3 and helps fight stress and anxiety, and even prevent depression. It also contains omega 6 fatty acids and vitamin E.

Advantageously, the composition according to the invention comprises omega-3 in the form of DHA, preferably in proportions of 5 to 12%, more preferably in proportions of 7 to 10% by weight of said composition .

Advantageously, the composition according to the invention may comprise at least one prebiotic, such as inulin, preferably chicory inulin. Chicory inulin is a water-soluble, low-calorie dietary fiber that stimulates the development of bacteria in the intestinal flora and regulates blood sugar.

In order to be able to obtain a composition incorporating a high content of taurine, a molecule which is very poorly soluble in lipids, the present invention comprises a thickening agent chosen from an edible wax with a melting point of between 55 and 85°C. This makes it possible to obtain a composition capable of thickening on standing at room temperature (20 to 25° C.) and of taking on a fluid appearance when stirred, while retaining its homogeneity.

Oral administration is facilitated, for example by spoon.

Advantageously, said edible wax is a natural wax, preferably chosen from beeswax, candelilla wax, sunflower wax, carnauba wax, mimosa wax, or a mixture of those -this.

According to a preferred embodiment of the invention, the food wax is beeswax, preferably present in proportions of 1 to 5%, more preferably 2 to 4% by weight of the composition.

The composition according to the invention may also comprise, preferably at a total content not exceeding 2% by weight of the composition, vitamins such as vitamins E, D, and/or coenzyme Q 10.

The composition according to the invention may also comprise, preferably in a total content not exceeding 2% by weight of the composition, amino acids, other than taurine, including leucine and/or arginine. [0029] Arginine has antioxidant properties, helps cognition and stimulates growth hormone.

[0030] Leucine is known to act on the nervous system and neurological functions.

A selenium supplementation, for example in the form of sodium selenite, may be provided in said composition at a content of between 0.2 and 0.5% by mass. Indeed, selenium is an essential trace element, in particular for its cardiac functions, which is deficient in patients usually on a ketogenic diet.

According to a preferred embodiment of the invention, the composition comprises the following percentages by weight: hemp oil 20 to 25%, virgin coconut oil 20 to 25%, 20-25% MCT coconut oil, 5-10% DHA, 5-15% taurine, 2-10% inulin, edible wax, melting point 55-85° C, 1 to 5%, optionally, at a total content not exceeding 2% by weight of the composition, of vitamins and/or coenzyme Q 10, and optionally, at a total content not exceeding 2% by weight of the composition, amino acids including leucine and/or arginine.

The above composition is balanced in terms of lipids: balanced in omega 3/6/9, DHA and MCT, and with a reduced intake of carbohydrates (carbohydrate content less than or equal to 1%, preferably less than or equal to at 0.5% by mass), which will facilitate the production of ketone bodies, and therefore the body's state of ketosis. These ketone bodies are the new source of energy necessary for the functioning of the organs, the brain and the heart... They will also help to improve the absorption of vitamin D, Coenzyme Q10 and taurine at the intestinal level. , promoting a good intestinal microbiota and the production of neurotransmitters. Indeed, ketone bodies and MCT oils will become "carriers" via the portal vein and not via the lymphatic system: access is more direct, efficient and rapid at the neuronal level.

The composition according to the invention can thus accompany and maintain the monitoring of a ketogenic diet, in particular in patients suffering from epilepsy. The present invention also relates to a method for preparing the composition for the ketogenic diet described above comprising the following steps:

- mixing with stirring at a temperature at a temperature at which the edible wax is liquid, said wax and virgin coconut oil,

- addition to said mixture with stirring of MCT coconut oil, hemp oil and taurine, at a temperature above 35°C,

- then after cooling to a temperature of 20 to 25°C, introduction, still with stirring, of DHA oil, inulin, any vitamins and/or coenzyme Q 10, and any amino acids, and

- obtaining a composition capable of thickening on standing at room temperature of 20 to 25 ° C and of regaining a fluid appearance under stirring, while retaining its homogeneity.

The method of the invention does not alter the intrinsic properties of the lipid components of interest for the production of ketone bodies.

Thus the composition according to the present invention, obtained by this process is a suspension in an oily medium, stable over time, whether after a stay in the cold (refrigerator) or exposure to moderate heat (25-30 ° C) (mixed with another food for example).

[0038] EXAMPLE

A non-limiting example of making a composition according to the invention is presented below; the amounts are expressed as % by mass of the final composition.

Lipid constituents (Manufacturers):

- hemp oil (EXINNOV) 24.0%

- virgin coconut oil (AKEMIA BIO) 24.0%

- MCT coconut oil (CAMBRIGE) 23.2%

- DHA 550-Y (FERMENTALG) 10.0%

- Taurine 10.0%

- Beeswax (COOPER) 2.5%

Other constituents:

- chicory inulin (GONMISOL) 5% - Coenzyme Q 10 1%

- Vitamin E 0.3%

Vitamin D3 0.01%

The carbohydrate content of this composition is 0.5% by mass.

You can also add to this composition:

- sodium selenite 0.25 mg / 100 g.

The minimum recommended dose per intake is 10 mL of this composition, in addition to a separate diet providing proteins. It does not require any dilution or special preparation and can therefore be administered directly, in particular with a spoon, or incorporated into food (on vegetables) or a drink (for example coconut milk).

A dose of 10 mL of this composition corresponds to 320 kcal.

[0042] The composition comprises a diversity of the nature of the lipids. The presence of coconut oils improves the taste aspect and the slightly pasty texture of the composition allows administration under the tongue, offering the advantage of sublingual absorption.

The process for preparing said composition firstly comprises mixing, with stirring, in a water bath at a temperature of between 60 and 70° C., beeswax and virgin coconut oil. , then adding to said mixture, with stirring, MCT coconut oil, hemp oil and then powdered taurine. The mixture is kept under stirring until it cools to 20 to 25°C. Still under agitation, inulin, coenzyme Q 10, DHA oil, then any vitamins and any amino acids are then successively introduced. The final mixture is kept stirring for at least 10 min, then packaged in a bottle.

It is noted that previous tests without MCT oil did not make it possible to obtain compositions with such high levels of taurine. It was thus able to be observed that the presence of the TCM triglycerides is essential to the production of the composition.

The composition obtained is a semi-liquid paste, capable of thickening on standing at room temperature of 20 to 25° C. and of resuming a fluid appearance with stirring, while retaining its homogeneity. The method according to the invention makes it possible to incorporate into said composition for the ketogenic diet a large quantity (10% in the example above) of taurine.

Claims

9 Claims

[Claim 1] Composition for a ketogenic diet, which can be administered orally, comprising a mass proportion of lipids of between 70 and 92%, including 30 to 65% of medium-chain triglycerides called TCM (triglycerides of C 12 to C 12 fatty acids), and 5 to 15% taurine, preferably between 7 and 12% taurine.

[Claim 2] Composition according to Claim 1, characterized in that the MCT triglycerides comprise coconut oils, preferably a mixture of virgin oil and refined oil, in proportions of 40 to 50% by weight of the composition.

[Claim 3] Composition according to Claim 1 or 2, characterized in that it also comprises hemp seed oil, preferably in proportions of 20 to 25% by weight of the composition.

[Claim 4] Composition according to any one of the preceding claims, characterized in that it comprises omega-3s in the form of DHA, preferably in proportions of 5 to 12%, more preferably in proportions of 7 to 10 % by weight of the composition.

[Claim 5] Composition according to any one of the preceding claims, characterized in that it comprises at least one prebiotic, such as inulin, preferably chicory inulin.

[Claim 6] Composition according to any one of the preceding claims, characterized in that it comprises a thickening agent chosen from an edible wax with a melting point of between 55 and 85°C.

[Claim 7] Composition according to Claim 6, characterized in that the edible wax is a natural wax, preferably chosen from beeswax, candelilla wax, sunflower wax, carnauba wax, mimosa wax , or a mixture thereof.

[Claim 8] Composition according to Claim 6 or 7, characterized in that the edible wax is beeswax, preferably present in proportions of 1 to 5%, more preferably 2 to 4% by weight of the composition.

[Claim 9] Composition according to any one of the preceding claims also comprising, preferably at a total content not not exceeding 2% by weight of the composition, vitamins such as vitamins E, D, and / or coenzyme Q 10.

[Claim 10] Composition according to any one of the preceding claims also comprising, preferably in a total content not exceeding 2% by weight of the composition, amino acids, other than taurine, including leucine and/or arginine.

[Claim 11] Composition according to any one of the preceding claims, characterized in that it comprises the following percentages by weight: hemp oil 20 to 25%, virgin coconut oil 20 to 25% , 20 to 25% MCT coconut oil, 5 to 10% DHA, 5 to 15% taurine, 2 to 10% inulin, edible wax, with a melting point between 55 and 85°C, 1 to 5%, optionally, at a total content not exceeding 2% by weight of the composition, of vitamins and/or coenzyme Q 10, and optionally, at a total content not exceeding 2% by weight of the composition, amino acids including leucine and/or arginine.

[Claim 12] Process for the preparation of the composition for ketogenic diet according to claim 11 comprising the following steps:

- mixing with stirring, at a temperature at which the food wax is liquid, of said wax and virgin coconut oil,

- then after cooling to a temperature of 20 to 25°C, introduction, still stirring, of DHA oil, inulin, any vitamins and/or coenzyme Q 10, and any amino acids,

- obtaining a composition capable of solidifying on standing at room temperature of 20 to 25 ° C and of resuming a fluid appearance under stirring, while retaining its homogeneity.