KR101876534B1 - Composition for preventing or improving nonalcoholic fatty liver disease - Google Patents

Abstract

The present invention relates to a composition for inhibiting liver fat accumulation comprising an active ingredient, and a pharmaceutical composition and a food composition using the same.

Description

[0001] The present invention relates to a composition for prevention or improvement of nonalcoholic fatty liver disease,

The present invention relates to a pharmaceutical composition and a food composition for preventing or ameliorating a non-alcoholic fatty liver disease comprising as an active ingredient, and more particularly, to a composition for preventing or alleviating non-alcoholic fatty liver disease To a composition for inducing improvement.

Fatty liver disease, also called fatty liver disease, is a disease caused by abnormal accumulation of fat (triglycerides, etc.) in hepatocytes, resulting in hepatic damage. It is known that the initial condition of fatty liver disease is a simple fatty liver that recognizes only fat deposition in hepatocytes, and then the condition progresses to fatty liver (including liver fibrosis), and also cirrhosis or hepatocellular carcinoma. In general, the causes of fat deposition in the liver include alcohol consumption, obesity, diabetes, lipid metabolism disorders, drugs (steroids, tetracyclines, etc.), Cushing's syndrome, poisoning .

The causes of fatty liver disease are largely divided into alcoholic and non-alcoholic. Liver disease caused by the former is called alcoholic fatty liver disease (also called alcoholic liver disease) and the latter is caused by nonalcoholic fatty liver disease : NAFLD, or nonalcoholic steatohepatitis.

Nonalcoholic steatohepatitis (NASH), a non-alcoholic steatohepatitis (NAH), which develops in association with hepatocellular inflammation, (Ludwig J et al., Mayo Clin. Proc. 1980, 55 (7): 434-438), which refers to a wide range of diseases including liver fibrosis and cirrhosis.

Non-alcoholic fatty liver disease is a disease characterized by fatty changes (steatosis) and lobular hepatitis (steatohepatitis), which are characteristic features of alcoholic hepatitis in liver biopsy, despite the absence of alcohol- . The pathologic findings of liver disease are diverse spectrum from non-alcoholic fatty liver (NAFL) to non-alcoholic steatohepatitis (NASH), fibrosis associated with fatty liver, liver cirrhosis, Is used to mean including.

There are no established therapies for this nonalcoholic fatty liver disease because it is associated with diverse factors such as diabetes, obesity, coronary artery disease, and sitting habits. Obesity is an important target in the treatment of nonalcoholic fatty liver disease. Weight loss is a factor associated with insulin resistance, the risk of liver damage, the amount of fatty acids entering the liver, and the decrease in inflammatory or fibrotic adipokines . ≪ / RTI > Alterine alanine aminotransferase (ALT) levels and triglyceride content in the liver may be reduced by dietary control and exercise-induced weight loss, but improvements in weight loss in patients with necrotizing inflammation or liver fibrosis Little is known.

As described above, in the case of nonalcoholic fatty liver disease, sufficient treatment is not established and it is important to prevent or prevent nonalcoholic fatty liver disease in advance.

An example of the present invention provides a pharmaceutical composition or food composition for preventing or ameliorating a non-alcoholic fatty liver disease comprising an active ingredient.

Another embodiment of the present invention provides a pharmaceutical composition or food composition for alleviating, preventing, ameliorating or inhibiting nonalcoholic fatty liver disease through inhibition of liver fat accumulation comprising an active ingredient.

The present invention relates to a composition for preventing or ameliorating liver fat accumulation and non-alcoholic fatty liver disease comprising an active ingredient, for example, a pharmaceutical composition or a food composition.

The composition comprising the active ingredient of the present invention inhibits the accumulation of liver fat, suppresses the decrease of muscle tissue, and improves body composition.

Nonalcoholic steatohepatitis (NASH), a non-alcoholic steatohepatitis (NAH), which develops in association with hepatocellular inflammation, (Ludwig J et al., Mayo Clin. Proc. 1980, 55 (7): 434-438), which refers to a wide range of diseases including liver fibrosis and cirrhosis.

Non-alcoholic fatty liver disease is a disease characterized by fatty changes (steatosis) and lobular hepatitis (steatohepatitis), which are characteristic features of alcoholic hepatitis in liver biopsy, despite the absence of alcohol- . The pathologic findings of liver disease are diverse spectrum from non-alcoholic fatty liver (NAFL) to non-alcoholic steatohepatitis (NASH), fibrosis associated with fatty liver, liver cirrhosis, Is used to mean including.

In the composition containing the psicose as an active ingredient according to the present invention, the amount of change in body fat amount measured by DXA at 12 weeks relative to the baseline time showed a statistically significant difference between the three groups. Lean body weight refers to the amount of body weight, moisture, muscle protein, and bone, excluding fat, measured as a result of changes in other constituents of the body other than fat, or a change in body fat Able to know. In the composition containing the psicose as an active ingredient according to the present invention, there was no significant difference in the low fat dose group and the high fat dose group in the 12 week analysis compared to the baseline time point, , Respectively. Since the decrease in body fat amount is statistically significant, it can be confirmed that the cause of the decrease in body weight is due to the change in body fat. Even if the body fat accumulation inhibitory effect is effective, the change of other beneficial body components (moisture, muscle, bone, etc.) It is possible to achieve a healthily very desirable result.

Saikoshi may be a composition that is statistically significantly inhibiting lean body weight reduction. The suppression of the decrease in the amount of fat may be that the mean amount of change in the amount of fat measured before / after the administration is within 1.5%, preferably within 1.0% at the 12th week from the base point.

Liver HU mean value, Liver - Spleen HU, Liver / Spleen HU items of control group showed a decreasing tendency and there was statistically significant difference between before and after. In the present study, serum liver enzyme markers reflecting liver function were commonly improved after taking cicos-cohort, and nonalcoholic fatty liver disease is considered another phenotype of obesity-induced metabolic syndrome. In conclusion, the results of the analysis of the above components showed that Sycor suppressed body fat accumulation and muscle mass loss.

In addition, in the experimental results, the levels of Alkaline phosphatase and γ-GTP were significantly higher in the high-dose group and the low-dose group than in the control group at 12 weeks compared to baseline, There was statistically significant difference between before and after. There was a statistically significant difference between the three groups in the high dose group and the low dose group and in the high dose group. Nonalcoholic fatty liver disease is another phenotype of obesity-induced metabolic syndrome.

The content of the cytosine contained in the composition according to an embodiment of the present invention is not particularly limited and may be, for example, 0.01 to 100% by weight based on the total weight of the final composition.

The subject to which the composition according to the present invention is administered may be a subject in need of inhibiting hepatic fat accumulation and may be an animal including a normal human or a patient. It may also be a normal person with liver fat accumulation inhibition or nonalcoholic fatty liver disease, a risk of having the disease, or a cause of the disease, such as obesity or overweight.

As used herein, the term " administration " means the act of introducing a composition of the present invention to a subject in any suitable manner, and the administration route can be administered through various routes of oral or parenteral administration, , Preferably oral administration.

The administration frequency of the composition of the present invention is not particularly limited, but it may be administered once to four times per day, or divided into several doses. For example, when the cyclosporine is administered 1 to 4 times a day, it can be uniformly divided into the same amount or divided into different amounts and administered.

The daily dose of the above-mentioned cyclosporine may be an amount of 0.05 to 0.75 g, more preferably 0.05 to 0.75 g per kg body weight of the subject, and is 3 to 45 g, preferably 60 to 60 g, 3 to 25 g, and more preferably 6 to 12 g.

The composition of the present invention may be in the form of a powder or syrup containing the compound of the present invention. For example, the compound of the present invention may be prepared by dissolving 90% Or may be a solution that has been converted to a corycoside by biological methods.

Saikosu may be used alone or in combination with other saccharides. Examples of mixed sugars may contain from 1 to 99.9 parts by weight of Saikosu based on 100 parts by weight of solids in the total mixed sugar , And may further include at least one member selected from the group consisting of fructose, glucose, and oligosaccharides.

Specific examples of the saccharide-containing mixed sugar include 2 to 55 parts by weight of psicose, 30 to 80 parts by weight of fructose, 2 to 60 parts by weight of glucose, and 0 to 15 parts by weight of oligosaccharide based on 100 parts by weight of the total solid content of the mixed sugar And may not include oligosaccharides. Saikos, fructose and glucose are preferably both D-isomer.

Saikosu can be carried out by chemical synthesis, or by biological methods using a cyclic epimerase, preferably by a biological method. Thus, the above-mentioned psicose includes at least one selected from the group consisting of psicose epimerase, cells of the strain producing the enzyme, culture of the strain, lysate of the strain, and extracts of the lysate or the culture The composition for producing psicose may be one prepared by reacting with a fructose-containing raw material. In one embodiment of the present invention, a method for producing a scikos according to a biological method includes a method of culturing a strain producing a < RTI ID = 0.0 > cytokine < / RTI > epimerizing enzyme or a recombinant strain into which a gene encoding a scikos epimerase has been introduced, The course epimerase can be produced by reacting with a fructose-containing raw material. The above-mentioned cyclic epimerase can be carried out as a solid phase reaction using a liquid phase reaction or an immobilized enzyme.

Alternatively, a strain producing a cytomegalovirus or a recombinant strain into which a gene encoding a cytomegalovirus is introduced is obtained, and the culture of the strain, the culture of the strain, the lysate of the strain, and the lysate of the lysate or the culture Extract of the present invention can be produced by reacting a composition for producing a scorch, which comprises at least one member selected from the group consisting of a fructose-containing raw material, and a fructose-containing raw material. In the case of producing the cytosine using bacterial strains producing the Escherichia epimerase, the reaction can be carried out in the solid phase reaction using a liquid reaction or immobilized cells.

In the above-mentioned method of producing a sciucose, the concentration of fructose used as a substrate is 20 w / v% or more, for example, 40 to 98% (w / v) or 40 to 95% w / v), for example from 40 to 75% or from 50 to 95% (w / v). The concentration of fructose can be appropriately selected in consideration of economical efficiency of the process and solubility of fructose. The fructose may be used in the form of a solution dissolved in a buffer solution or water (e.g., distilled water).

Detailed description of the preparation method and the preparation method thereof is disclosed in Korean Patent Publication Nos. 2014-0021974, 2014-0080282 and Korean Patent No. 10-1318422.

The food composition of the present invention can be manufactured in various forms according to a conventional method known in the art, and Saikos can be manufactured and supplied in the form of food, beverage, food additive, beverage additive, health functional food, have. For example, it can be a health food preparation such as a tea, a juice, a carbonated drink, an ionic beverage, a drink, a beverage such as a drink, a powder, a tablet or a capsule, a food such as a gum, a confection, a bread and a cotton. The food composition of the present invention may contain sweetening agents, flavoring agents, flavoring agents and the like in addition to the active ingredients thereof. In addition, the food composition of the present invention may contain preservatives, emulsifiers, thickeners and the like as necessary. The food of the present invention can be manufactured and processed in the form of tablets, capsules, powders, granules, liquids, and circles for the purpose of preventing or improving nonalcoholic fatty liver disease.

In the present invention, the term " health functional food " refers to foods prepared (including processing) by using raw materials or ingredients having functionality useful to the human body according to the Act on Health Functional Foods, To maintain the function or to maintain and improve the health through the activation of the physiological function, and the like. In addition, the above-mentioned functionalities have a special effect on nutrient function, normal function or biological activity of the human body, which is the physiological function of the nutrient on the growth and promotion of the human body and the normal function, An active function, or a disease incidence reduction function in which ingestion of food is an action that reduces the risk of disease occurrence or health condition.

The food is not particularly limited as long as it is an alulose applicable food. For example, the food is not limited as long as it is an alululose-applicable food. Examples of the food include almonds, cereals, processed foods, processed foods, processed sugars, processed marine products, ), Breads, dumplings, processed meat products, processed egg products, processed foods, processed noodles, processed noodles, other noodles, boiled noodles, solid tea, liquid tea, coffee, fruit juice, fruit juice, other fermented beverages, , Seasoned soybean paste, kochujang, chungkukjang, sauce, compound seasoning food, cabbage kimchi, seasoned seafood, pickles, pickles, farm produce, livestock products, seasoned dried persimmon, dried persimmon, peanut or nuts processed products, (Noodles, noodles, etc.), gums, ice cream, alcoholic beverages, vitamin complexes, and health supplements, as well as processed foods, processed foods, Pumryu and the like.

The food according to the present invention may contain conventional food additives and the suitability of the food additives as a food additive is not limited so long as the standard for the relevant item is applied in accordance with the General Rules for Food Additives approved by the Food and Drug Administration, And standards.

Examples of the substances described in the above-mentioned "food additive process" include chemical compounds such as ketones, glycine, calcium citrate, nicotinic acid, and cinnamic acid; Natural additives such as persimmon extract, licorice extract, crystalline cellulose, high color pigment and guar gum; L-glutamic acid sodium preparations, noodle-added alkalis, preservative preparations, tar coloring preparations and the like. The composition for preventing or ameliorating nonalcoholic fatty liver disease according to the present invention can be used as a pharmaceutical composition or a food composition.

In an embodiment of the present invention, the pharmaceutical composition for preventing or ameliorating non-alcoholic fatty liver disease can be prepared from a pharmaceutical composition. The pharmaceutical composition according to the present invention can be administered orally or parenterally, and is preferably administered orally.

The pharmaceutical composition according to the present invention comprises a pharmaceutically acceptable carrier. The carrier is usually used at the time of formulation and may be selected from lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone , Cellulose, water, syrup, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil, and the like. The pharmaceutical composition according to the present invention may further contain lubricants, wetting agents, sweeteners, flavors, emulsifiers, suspending agents, preservatives, etc., in addition to the above-mentioned components, if necessary. For reference, suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington ' s Pharmaceutical Sciences (19th ed., 1995).

The appropriate dosage of the pharmaceutical composition according to the present invention may vary depending on factors such as the formulation method, the administration method, the age, body weight, sex, pathological condition, food, administration time, administration route, excretion rate, It can be prescribed.

The pharmaceutical composition of the present invention can be prepared in unit dosage form by incorporating into a pharmaceutically acceptable carrier and / or excipient, or by inserting it into a multi-dose container.

The present invention relates to a pharmaceutical composition and a food composition for preventing or ameliorating a non-alcoholic fatty liver disease comprising as an active ingredient, and more particularly, to a composition for preventing or alleviating non-alcoholic fatty liver disease To a composition for inducing improvement.

1 is a schematic diagram illustrating a human body testing method according to an embodiment of the present invention.

Hereinafter, the present invention will be described in more detail with reference to the following examples. However, these examples are only for illustrating the present invention, and the scope of the present invention is not limited by these examples.

Manufacturing example  One. Saikos  Produce

The Saikosu powder used in the following examples was prepared according to the methods described in Korean Patent Publication Nos. 2014-0021974, 2014-0080282 and Korean Patent No. 10-1318422.

Example  1: Effectiveness test

(1) Target selection

A screening test was conducted for those who agreed in writing and agreed to the selection / exclusion criteria after hearing detailed explanation of the purpose and method of the present embodiment. The selected criteria are as follows. The final selected subjects are 99 male and female adults who are overweight or obese. The demographic information of the selected subjects is shown in Table 1 below.

Selection Criteria

1. Adult men and women aged 19 to 65

2. BMI is 23kg / m ² more than 30kg / m of less than ^two overweight adults

In the case of pregnant women,

4. Modifiable patients (such as diabetes or hypertension): Includes patients who are well-controlled as a drug. 10% of patients have hypertension and 5% have diabetes.

In the high dose group, 5 (15.15%) were female, 28 (84.85%) were female, 6 were male (18.18%) and 27 were female (81.82%) in the high dose group, ) In the control group, 2 (6.06%) in males and 31 (93.94%) in females. The high-dose group had a mean age of 45.06 years (range 25 to 65 years), the low-dose group was 41.52 years (range 26 to 61 years), and the control group was 44.61 years (range 26 to 63 years) , And there was no statistically significant difference in the distribution of subjects in both sexes and ages.

The subjects selected by the 99 subjects were divided into 3 groups, and the test subjects were finally decided with the high capacity group (33 persons), the low capacity group (33 persons) and the control group (33 persons).

(2) Test products

The test subjects were divided into 3 groups according to the number of subjects selected as 99 subjects. The subjects were divided into three groups: high dose group (33 subjects), low dose subjects (33 subjects) and control subjects (33 subjects). The high dose test group was provided with a high-dose product, the low dose test group was given a low dose product, and the control group was given a placebo product.

The product group was stored in a hermetically sealed container at room temperature (1 to 30 DEG C), in a dry, well-ventilated place.

product name Saikosu high capacity Low-dose Placebo Ingredients Saikos Sicose, anhydrous glucose Anhydrous glucose Properties and Formulation White crystalline powder White crystalline powder White crystalline powder Amount of raw material product Saikosu 12 g / d Saikosu 6 g / d,
Anhydrous glucose 6 g / d Anhydrous glucose 12 g / d Packing unit 6g / bag 6g / bag 6g / bag

( 3) ingestion  Way

Eighty - nine subjects were randomly assigned to high dose, low dose or control groups, and 33 subjects were included in each test group. In the three test groups, 100 ml of water was taken twice a day and taken orally.

The daily intake of 1 test subject was divided into 2 divided doses per day in the high dose group, 12 g of the low dose group, 6 g of the low dose group and 6 g of the anhydrous glucose and 12 g of the anhydrous glucose in the control group. The rats were randomly assigned to eat on the next day (0 day). They were fed with meals twice a day, morning and evening, for 12 weeks.

The efficacy evaluation items and safety evaluation items such as DXA measurement were performed on the random assignment date (0Day), and the evaluation items for the visit were determined through outpatient visits at 4 weeks, 8 weeks, and 12 weeks Respectively. During the test period, the Korean version of the physical activity questionnaire (IPAQ) was used to investigate the physical activity of the subjects. During the test period, the training was conducted to maintain the activity level similar to the normal physical activity level. Dietary intake was investigated using the diaries recorded by subjects during each visit. Dietary intake was also similar to that of usual meals, but education was conducted to avoid overeating.

Example  2: Validity evaluation method

(One) DXA Measured by Body fat and Fat content (lean body mass)

Body fat ratio and body fat were measured using the Lunar prodigy DXA at Visit2 and Visit5.

After calculating the change of body fat mass after 12 weeks compared to baseline, the descriptive statistics (mean, standard deviation, median, minimum, and maximum values) were calculated, and ANOVA or Kruscal -Wallis test, and multiple comparisons were made using the Tukey-Kramer method if there were significant differences between the groups. We used Paired t-test or Wilcoxon's signed rank test to determine whether there was any difference in the mean change between groups.

(2) Party index  inspection

FBS, insulin, and HbA1c test were performed at the time of screening visit (Visit1), visit 2 (Visit2) and end visit (Visit5) using collected blood.

(Mean, standard deviation, median, minimum value, maximum value) were calculated after calculating the average change of the glucose index (FBS, Insulin, HbA1c) after 12 weeks compared to the baseline point and ANOVA The Kruscal-Wallis test was used to compare the three groups, and the Tukey-Kramer method was used for multiple comparisons. We used Paired t-test or Wilcoxon's signed rank test to determine whether there was any difference in the mean change between groups.

(3) Liver CT

To assess the degree of local deposition at Visit2 and Visit5, we measured liver HU, spleen HU, liver and spleen HU difference (Liver minus Spleen), liver and spleen HU (Ratio Between Liver and Spleen) were measured. CT attenuation values (Hounsfield units) were measured 3 times in the regions of interest (ROI) of the right lobe and spleen, which were selected as homogeneous regions from the blood vessels in one nonenhanced CT image including both liver and spleen. The mean value was defined as the CT attenuation number. At this time, the size of each area of interest is equally set to 120 mm ² .

Liver CT scans were used to describe the mean changes in liver, liver, and spleen HU, liver and spleen HU, liver and spleen HU ratios (Ratio Between Liver and Spleen) Statistical analysis (mean, standard deviation, median, minimum, and maximum values) was used to test for the normal distribution of data. ANOVA or Kruscal-Wallis test was used to compare the three groups. Multiple comparisons were made using the Kramer method. To determine whether there was a difference in the mean change between groups, paired t-test or Wilcoxon's signed rank test was used for comparison.

(4) Blood chemistry test result

Alkaline phosphatase, AST, ALT, and γ-GTP were tested at the screening visit (Visit1), visit2 (Visit2) and end visit (Visit5).

In the case of continuous data, descriptive statistics (mean, standard deviation, median, minimum, and maximum values) were presented for the mean change relative to baseline, and ANOVA or Kruscal- A comparison was made using the Tukey-Kramer method when there were significant differences between the groups. To determine whether there is any difference in the mean change between groups, normal distribution of data was tested and compared using Paired t-test or Wilcoxon signed rank sum test. Descriptive statistics (frequency, percentage) were presented for categorical data, and Chi-square test or Fisher's exact test was used to compare the three groups.

Example  3: Results of effectiveness evaluation

(One) DXA Measured by Body fat and Fat content (lean body mass)

In the ITT group, the mean changes of body fat were increased by 0.25 ± 1.34kg in the high dose group, 0.16 ± 0.91kg in the low dose group, (0.95 ± 1.65 kg), and there was a statistically significant difference between the three groups (p-value = 0.0358). In the control group, there was statistically significant difference between the baseline and 12 weeks (p-value = <0.0001).

There was no statistically significant difference between the three groups in the Lean items, and the mean change at 12 weeks compared to baseline was -0.61 ± 1.28 kg, which was statistically significant (p-value = 0.0048). The results for body fat mass measured by DXA are shown in Table 3 below.

The DXA measured body fat mass showed a statistically significant difference between the three groups at 12 weeks relative to baseline. In the control group, there was statistically significant difference between before and after increase of body fat mass, but there was no statistically significant difference between before and after.

Lean body mass decreased by -0.61 ± 1.28 kg after 12 weeks in the control group, but the difference was not observed between before and after the administration of the cyclosporine group. In the present study, the inclusion of overweight in the selection criteria of the subjects indicated that the subjects were mild obesity group (mean body mass index <27) and the number of subjects per group was insufficient to observe statistically significant changes in body weight or body mass index. And inhibited the decrease of muscle mass.

(2) Party index

In the ITT group, there was no statistically significant difference between the high - dose group and the low - dose group and the control group at 12 weeks after baseline in Glucose, Insulin, and HbA1c. Was not statistically significant, and there was no effect of blood glucose lowering in normal subjects. Table 4, Table 5 and Table 6 show the results of the party index analysis of the subjects to be analyzed.

(3) Liver CT

There was no statistically significant difference between the three groups in the mean change of 12 weeks compared to baseline in all items. Liver HU, Liver - Spleen HU, and Liver / Spleen HU of the control group showed a decreasing tendency and there was statistically significant difference (p - value = 0.0300, 0.0027, 0.0029).

4) Blood chemistry test result

(P-value = 0.0001), ALT (p-value = 0.0127) and gamma-GTP (p <0.05) p-value = 0.0043). There was a statistically significant difference between the three groups.

Alkaline phosphatase and γ-GTP were significantly higher in the high-dose group and the low-dose group than in the control group at 12 weeks compared to baseline, and statistically significant Respectively. There was a statistically significant difference between the three groups in the high dose group and the low dose group and in the high dose group.

lkaline phosphatase and γ-GTP were significantly higher in the high-dose group and the low-dose group than in the control group at 12 weeks compared to baseline, and statistically significant differences were found in the high-dose and low-dose groups Respectively. There was a statistically significant difference between the three groups in the high dose group and the low dose group and in the high dose group. In the present study, serum liver enzyme markers reflecting liver function were commonly improved after taking cicos-cohort, and nonalcoholic fatty liver disease is considered another phenotype of obesity-induced metabolic syndrome. In conclusion, the results of the analysis of the above components showed that Sycor suppressed body fat accumulation and muscle mass loss.

Example  4: Safety experiment

In the physical examination for safety testing, the low dose and high dose groups were normal or clinically meaningless abnormal findings in all items, and there was no statistically significant difference between the three groups. Physical examination The 12 detailed items (ITT, Ears / Nose / Throat, Eye, Head / Neck, Cardiovascular system, Abdomen, Respiratory system, Breast / Genitalia, Neurological system, Lymph nodes, Skin, Musculoskeletal etc) Normal, clinically significant, and abnormal (Clinically Significant). All of the items were classified as normal or clinically meaningless abnormal findings, and statistically significant There was no difference.

In addition, the mean systolic blood pressure change was 4.15 ± 10.30 mmHg in the high-dose group, 2.67 ± 9.71 mmHg in the low-dose group, and 1.73 ± 9.63 mmHg in the control group at 8 weeks from baseline, (P-value = 0.0349). There were no statistically significant differences in the diastolic blood pressure and pulse rate among the three groups.

In the laboratory tests, the mean difference between the groups was analyzed at 12 weeks relative to baseline, and Alkaline phosphatase (p-value = <0.0001), ALT (p-value = 0.0127) , and γ-GTP (p-value = 0.0043), respectively. There was no clinically meaningful abnormality in the urine test, and there was no statistically significant difference between the three groups in all items.

Claims (12)

The present invention relates to a food composition for suppressing body fat accumulation and lean body weight reduction,
Saikosuke is a powder obtained from syrup of mixed sugar or mixed syrup and contains 2 to 55 parts by weight of psicose, 30 to 80 parts by weight of fructose, 2 to 60 parts by weight of glucose, and 2 to 60 parts by weight of oligosaccharide based on 100 parts by weight of total solids content of the mixed sugar. 0 to 15 parts by weight,
Wherein the mixed syrup contains at least one member selected from the group consisting of a cytosine epimerase, a strain of the strain producing the enzyme, a culture of the strain, a lysate of the strain, and an extract of the lysate or the culture A composition for producing psicose, which is produced by reacting with a fructose-containing raw material,
The daily dose of the above-mentioned cyclosporin is 0.05 to 0.75 g per kg body weight of the subject,
Wherein the suppression of lean body mass reduction is such that the mean amount of change in lean body mass measured before and after the administration of Saikos is within 1.5% of the baseline time point at 12 weeks. delete 3. The food composition of claim 1, wherein the daily dose of Saikos is administered to the subject at 3 to 45 g. 4. The food composition of claim 3, wherein the daily dose of Saikos is administered in a divided dose of 1-4 times. delete The food composition according to claim 1, wherein the Saicos inhibits liver fat accumulation. delete delete delete delete delete The food composition according to claim 1, wherein the food is a health functional food.

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