Dietary supplement indicated for the treatment of liver diseases based on phosphatidylcholine, capsule comprising said supplement, and its use

Abstract

The present invention relates to a dietary supplement specifically indicated for the treatment of liver diseases based on phosphatidylcholine, and more particularly to a dietary supplement that aids in the treatment of liver disorders and associated toxicity. The composition comprises compounds such as phosphatidylcholine, inositol, L-methionine, and vitamins, which provide physiological benefits, especially for individuals seeking to improve liver function affected by oxidative stress. The present invention further relates to a capsule comprising said dietary supplement and its use in the treatment of liver diseases based on phosphatidylcholine.

Description

FOOD SUPPLEMENT INDICATED FOR THE TREATMENT OF LIVER DISEASES BASED ON PHOSPHATIDYLCHOLINE, CAPSULE COMPRISING SAID SUPPLEMENT AND ITS USE FIELD OF INVENTION

[0001] . The present invention belongs to the Food technology sector and refers to a food supplement particularly indicated for the treatment of liver diseases based on phosphatidylcholine, more specifically to a food supplement to aid in the treatment of liver diseases as well as their toxicity, comprising compounds such as phosphatidylcholine, inositol, methionine, vitamins, which bring benefits to the body especially for people seeking help in improving liver function due to oxidative stress in the organ.

[0002] . The present invention also relates to a capsule comprising said food supplement and its use in the treatment of liver diseases based on phosphatidylcholine. BACKGROUND OF THE INVENTION

[0003] The liver is a vital organ, responsible for numerous physiological processes. With changes in the population's diet and lifestyle habits, the prevalence of obesity and other chronic noncommunicable diseases has increased. Associated with the liver's important functions, an increase in nonalcoholic fatty liver disease (NAFLD) can be observed.

[0004] The liver is a center responsible for several physiological processes such as: macronutrient metabolism, immune system support, blood volume regulation, endocrine control of growth signaling pathways, lipid and cholesterol homeostasis, and the breakdown of xenobiotic compounds, such as medications.

[0005] . Macronutrient metabolism is among the most important functions important functions of the liver, as it is a process that also provides the energy needed to perform other functions. Furthermore, the liver has the ability to store glucose in the form of glycogen and, through the gluconeogenic pathway, in response to fasting, to form glucose.

[0006] . It is also responsible for oxidizing lipids and participates in the metabolism of proteins and amino acids, as it is responsible for the majority of proteins secreted into the blood, for the processing of amino acids for energy and also for the elimination of nitrogenous waste from protein degradation.

[0007] A growing concern is the hepatic response to dietary changes, as one of these responses is non-alcoholic fatty liver disease, and its increasing incidence in different countries appears to partly explain the new pandemic of chronic liver disease. Therefore, it is important to understand the functional consequences of this condition.

[0008] Fatty liver disease affects not only the liver but also triggers a series of cardiovascular, neurological, and renal complications, making treatment crucial for improving patients' survival and quality of life. It is worth noting that fatty liver disease carries an increased risk of developing steatohepatitis, as well as cirrhosis and hepatocellular carcinoma. Therefore, several treatments are still being studied to prevent and slow the progression of the disease.

[0009] The liver is critical for lipid and cholesterol metabolism. The liver uses fatty acids as an internal energy source through oxidative pathways, but it can also supply energy to other organs through the production of ketone bodies and gluconeogenesis. Furthermore, the liver combines fatty acids and glycerol into triglycerides, which are released with lipoproteins that can reach other organs such as adipose tissue for storage or skeletal muscle for use as an energy source. It is worth noting that lipid metabolism It is also critical for the absorption of fat-soluble vitamins.

[0010] Steatosis is becoming an increasingly well-known liver disease among the general population. This is due to the increased availability of abdominal ultrasounds, an imaging test that can detect steatosis and is frequently performed in routine clinical evaluations; and the growing prevalence of obesity worldwide, which is one of its main causes.

[0011] Steatosis is characterized by the excessive accumulation of fat (lipids) in liver cells called hepatocytes. This condition can remain stable for many years and even regress if its causes are controlled. If not, the disease can progress to steatohepatitis. At this stage, steatosis is associated with inflammation and cell death, fibrosis (scarring), and has a greater potential to progress over time to cirrhosis and hepatocellular carcinoma (HCC) or liver cancer.

[0012] Non-alcoholic fatty liver disease (NAFLD) is characterized by excess fat in the liver and can affect both those who do not consume alcohol and those who consume it in small amounts. Approximately 31% of the American population has been diagnosed with this disease, with cases increasing among children, adolescents, adults, and the elderly. The incidence ranges from 10% to 40%, depending on the population, and when considering the obese population, the number can increase from 57.5% to 74%.

[0013] . Thus, metabolic pathways have been increasingly studied, with the aim of increasing treatment strategies, and thus, elucidating mechanisms that may be alternatives, both for treatment and prevention, to those usually known.

[0014] . We highlight below some teachings from the state of the art that refer to this matter:

[0015] . Document PI 9909988-8 deals with a method for modulating cytokine-mediated liver injury by administering deltorphins to a mammal. Deltorphin I SEQ ID NO:1 and deltorphin I SEQ ID NO:2, or combinations of deltorphin I SEQ ID NO:1 and deltorphin I SEQ ID NO:2, may be administered. A deltorphin concentration ranging from about 0.5 mg / kg to about 20 mg / kg in a physiologically acceptable formulation blocks the cytokine cascade in a murine model of septic shock. It also relates to a therapeutic method for modulating trauma-induced and toxin-induced cytokine-mediated acute inflammatory liver injury, particularly through the modulation of tumor necrosis factor, is thus disclosed.

[0016] . Document BR 11 2023008468-7 refers to a pharmaceutical composition comprising at least one methylcyclodextrin for the treatment and / or prevention of hepatic steatosis and related diseases. It refers to the use of methylcyclodextrin to reduce lipid accumulation in the liver.

[0017] . Document BR 11 2023 002069-7 provides a therapeutic agent for fatty liver disease.

[0018] . BR 11 2022 010613-0 discloses certain nucleic acids (e.g., double-stranded siRNA molecules) as well as conjugates comprising a targeting moiety, a double-stranded siRNA, and optional linking groups. Certain embodiments also provide useful synthetic methods for preparing the conjugates. The conjugates are useful for treating certain diseases, such as liver fibrosis, e.g., in the setting of NASH or HAE.

[0019] . Document BR 11 2019 009581-0 deals with a composition for preventing or treating hepatitis, liver fibrosis and liver cirrhosis, specifically, it provides a fusion protein comprising a biologically active protein and a mutant FGF21 protein; and the pharmaceutical composition containing the fusion protein for preventing or treating hepatitis, liver fibrosis and liver cirrhosis through the effect of inhibiting the proliferation of inflammatory cells and fibroblasts.

[0020] . Therefore, as can be seen later, there is no solution in the state of the art equivalent to that presented here in the present invention that combines technical differences, economic advantages, safety and reliability. OBJECTIVES OF THE INVENTION

[0021] The objective of the present invention is to provide a dietary supplement to aid in the treatment of liver diseases and their toxicity. This dietary supplement has an innovative formula based on phosphatidylcholine, inositol, methionine, and vitamins.

[0022] . Another objective of the present invention is a preferred embodiment being a food supplement composition based on phosphatidylcholine, inositol, L-methionine, chlorophyll, vitamins E, B3, B12.

[0023] . The object of the present invention is to provide a dietary supplement indicated for the treatment of liver diseases that can be administered in a 1.5g capsule. SUMMARY OF THE INVENTION

[0024] . The present invention achieves these and other objectives by means of a food supplement particularly indicated for the treatment of liver diseases based on phosphatidylcholine comprising soy lecithin, grape seed oil, vitamin B3, vitamin B12, methionine, inositol, vitamin E and an acceptable vehicle.

[0025] . Furthermore, the present invention achieves these and other objectives by means of a capsule comprising the above dietary supplement.

[0026] . Furthermore, the present invention achieves these and other objectives through the use of the above food supplement for preparing a capsule indicated for the treatment of liver diseases based on phosphatidylcholine. DETAILED DESCRIPTION OF THE INVENTION

[0027] . The present invention is a dietary supplement particularly indicated for the treatment of liver diseases based on phosphatidylcholine comprising soy lecithin, grape seed oil, vitamin B3, vitamin B12, methionine, inositol, vitamin E and an acceptable vehicle.

[0028] . This composition may also comprise other components such as, for example, dye such as chlorophyll, double-distilled glycerin and gelatin such as granulated bovine edible gelatin.

[0029] . As can be seen later, the present invention brings technical advantages over the state of the art because:

[0030] Phosphatidylcholine is the most abundant phospholipid, comprising 40-50% of total cellular phospholipids. In recent years, the importance of phospholipids in regulating the body's lipid, lipoprotein, and energy metabolism has become increasingly evident. Furthermore, it is clear that phospholipid synthesis is vital for cell survival, normal development, and health maintenance. Therefore, small changes in phospholipid levels appear to have significant implications for parameters related to metabolic syndrome. One of the functions of phospholipids is the formation and stability of lipoproteins. Therefore, reduced phosphatidylcholine synthesis impairs the secretion of triacylglycerol-rich lipoproteins.Thus, reduced hepatic phosphatidylcholine synthesis impairs the secretion of very low-density lipoproteins, and changes in hepatic phospholipid composition have been associated with fatty liver disease and impaired liver regeneration, as this decreased hepatic phosphatidylcholine leads to an accumulation of triacylglycerols in the liver. Another apparent benefit of phosphatidylcholine is that increased levels are associated with protection against oxidative stress and liver fibrosis in humans with ethanol consumption. This finding corroborates a study in baboons that ingested ethanol for over six and a half years and were supplemented with a diet containing 94–98% ethanol. phosphatidylinositol, thus preventing the development of portal fibrosis and cirrhosis.

[0031] . Inositols are polyols that have many functions in biological systems. They are produced endogenously and can also be acquired through diet or dietary supplements.

[0032] . Data have shown that alterations in the absorption, metabolism and excretion of inositol appear to play a role in metabolic diseases and, therefore, the therapeutic role of inositol has been investigated and has shown potential benefits.

[0033] Methionine is an essential amino acid, meaning it is not synthesized in the body. It performs a variety of essential functions in cells and tissues. It plays a critical role in several metabolic processes, in addition to protein synthesis, and is the building block of all proteins. Studies have shown that methionine deficiency can limit the availability of phospholipid secretion.

[0034] Lipotoxicity and increased production of reactive oxygen species may also be a driver for the development of hepatic steatosis, as increased free radicals can result in overloaded and dysfunctional mitochondria and increased release of pro-inflammatory cytokines.

[0035] Vitamin E brings biochemical and histological benefits to the treatment of hepatic steatosis, as in a study that showed improvement in the histological characteristics of steatosis, mainly due to its potential antioxidant effect.

[0036] Grapeseed oil has been associated with several benefits, primarily due to its antioxidant effect. Among these benefits, it is worth mentioning its hepatoprotective effects, due to its antioxidant, free radical scavenging, and anti-inflammatory activities, mainly due to its protection against oxidative stress.

[0037] . Niacin helps with energy metabolism, protein, carbohydrate and fat metabolism, and the maintenance of mucous membranes.

[0038] . Vitamin B12 helps in the formation of red blood cells, the functioning of the immune system, energy metabolism, the metabolism of carbohydrates, proteins and fats, the metabolism of homocysteine ​​and the process of cell division.

[0039] In a preferred embodiment, the present invention comprises liquid soy lecithin in an amount of 0.49g, liquid grape seed oil in an amount of 0.37g, vitamin B3 (niacin or niacinamide powder) in an amount of 0.015g, vitamin B12 (methyl cobalamin 5%) in an amount of 0.000024g, L-methionine powder in an amount of 0.06g; inositol powder in an amount of 0.05g, oily vitamin E in an amount of 0.011g, granulated bovine edible gelatin in an amount of 0.09g and liquid double-distilled glycerin in an amount of 0.22g. It also comprises a vehicle, preferably water. It may also contain a colorant, preferably chlorophyll colorant, in an amount of 0.003g.

[0040] . In view of all the data, based on the results of studies evaluating the beneficial effects of compounds to aid in the treatment of liver diseases, as well as their toxicity, the present invention is an innovative dietary supplement combining compounds that, when together, offer a positive effect between phosphatidylcholine, inositol, methionine, vitamins E, B3 and B12 that bring benefits to the body, especially for people seeking help in improving liver function due to oxidative stress in the organ, whether due to the use of alcoholic beverages, medications and also for support in the treatment of hepatic steatosis: - Phosphatidylcholine: important for the homeostasis of lipid and cholesterol metabolism, preventing the accumulation of triacylglycerides in the liver, as it participates in the secretion of lipoproteins; - Methionine: participates in the biosynthesis of phosphatidylcholine, in addition to being an essential amino acid, with functions in metabolic processes and protein synthesis; - Inositol: has metabolic functions, in addition to having a potentially beneficial effect as support in the treatment of metabolic diseases, such as hepatic steatosis; - Grape seed oil: has a hepatoprotective effect, mainly due to its antioxidant and anti-inflammatory action; - Vitamin E: is an antioxidant, which helps protect against damage caused by free radicals; - Niacin: helps with energy metabolism, protein, carbohydrate and fat metabolism and the maintenance of mucous membranes; - Vitamin B12: helps in the formation of red blood cells, in the functioning of the immune system, in energy metabolism, in the metabolism of carbohydrates, proteins and fats, in the metabolism of homocysteine ​​and in the process of cell division.

[0041] . Having described an example of a preferred embodiment of the present invention, it should be understood that the scope of the present invention encompasses other possible variations of the inventive concept described, being limited only by the content of the appended claims, including possible equivalents.

Claims

CLAIMS 1. Food supplement particularly indicated for the treatment of liver diseases based on phosphatidylcholine, characterized by comprising soy lecithin, grape seed oil, vitamin B3, vitamin B12, methionine, inositol, vitamin E and an acceptable vehicle.

2. Supplement according to claim 1, characterized in that the soy lecithin is liquid soy lecithin in an amount of 0.49g.

3. Supplement according to claim 1 or 2, characterized in that the grape seed oil is liquid grape seed oil in an amount of 0.37g.

4. Supplement according to any one of claims 1 to 3, characterized in that vitamin B3 is niacin or niacinamide powder in an amount of 0.015g.

5. Supplement according to any one of claims 1 to 4, characterized in that vitamin B12 is methyl cobalamin 5% in an amount of 0.000024g.

6. Supplement according to any one of claims 1 to 5, characterized in that methionine is L-methionine powder in an amount of 0.06g.

7. Supplement according to any one of claims 1 to 6, characterized in that inositol is inositol powder in an amount of 0.05g.

8. Supplement according to any one of claims 1 to 7, characterized in that vitamin E is oily vitamin E being tocopherol acetate in an amount of 0.011g.

9. Supplement according to any one of claims 1 to 8, characterized in that it comprises gelatin, preferably granulated bovine edible gelatin, in an amount of 0.09g.

10. Supplement according to any one of claims 1 to 9, characterized in that it comprises double-distilled glycerin being preferably liquid double-distilled glycerin in an amount of 0.22g.

11. Supplement according to any one of claims 1 to 10, characterized in that it is comprised in a 1.5g capsule.

12. Capsule characterized by comprising a food supplement particularly indicated for the treatment of liver diseases based on phosphatidylcholine as defined in any one of claims 1 to 11.

13. Use of the food supplement as defined in any one of claims 1 to 11, characterized in that it is for preparing a capsule indicated for the treatment of liver diseases based on phosphatidylcholine.