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One of the comorbidities of obesity is nonalcoholic fatty liver disease (NAFLD). L-citrulline is a non-protein amino acid that has shown positive effects on the degree of fat retention and metabolic profile in NAFLD. The objective is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo and an experimental group that will receive 6 g of l-citrulline per day for eight weeks.
It is hypothesized that l-citrulline supplementation decreases liver enzymes and the degree of hepatic steatosis in adolescents with obesity. The aim of the study is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A prospective randomized, double-blind clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo (carboxymethyl cellulose) and an experimental group that will receive 6 g of pure l-citrulline per day per eight weeks. At the beginning and end of the intervention, anthropometric, biochemical and metabolic data will be evaluated, as well as tests of function and degree of hepatic steatosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrulline group | Experimental | Group of adolescents supplemented orally with 6 g / day of pure L-citrulline in capsules. The dose will be met by taking four (3 g) capsules in the morning before the first meal and four capsules (3 g) in the evening after the last meal. |
|
| Placebo group | Placebo Comparator | Group of adolescents supplemented with placebo (carboxymethyl cellulose). The indication for taking will be the same as in the experimental group, four capsules in the morning before the first meal and four capsules at night, after the last meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Citrulline supplement | Dietary Supplement | The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of hepatic steatosis | The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as:
| Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method. | Baseline to 8 weeks |
| Insulin | The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ma. E Garay-Sevilla, PhD | Universidad de Guanajuato | Principal Investigator |
| Verónica I Tovar-Villegass, Bachelor | Universidad de Guanajuato | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guanajuato | León | Guanajuato | 37000 | Mexico |
At the request of the researcher.
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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The intervention consists of the oral administration of placebo or l-citrulline as follows:
Group Placebo: Carboxymethyl cellulose will be used for the placebo group. Four capsules will be taken in the morning before the first meal and four capsules at night before going to sleep for eight weeks.
Group Citrulline: a dose of 6 g of citrulline will be used per day, distributed as 3 g (4 capsules) in the morning before the first meal and 3 g (4 capsules) in the evening before sleep, for eight weeks. Each capsule contains 750 mg of pure citrulline.
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The selection of which group each adolescent will belong to will be made by randomization by simple lottery by a researcher from the Department of Medical Sciences of the University of Guanajuato who is not involved in the treatment and follow-up of the participants and will be designated to a Placebo group and to the Citrulline group. The participants and the researcher will not know which group each adolescent belongs to.
| Carboxymethyl cellulose supplement | Dietary Supplement | The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo. |
|
| Baseline to 8 weeks |
| Insulin resistance | The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels. | Baseline to 8 weeks |
| Lipid profile | The lipid profile will be measured by the modified Huang method of the Spinreact brand. | Baseline to 8 weeks |
| LDL-cholesterol | LDL-cholesterol will be determined using the Friedwald formula. | Baseline to 8 weeks |
| Urea levels | Urea levels will be obtained by the Urease GLDH kinetic method. | Baseline to 8 weeks |
| Uric acid levels | Uric acid will be evaluated by peroxidase enzymes and colorimetry. | Baseline to 8 weeks |
| Liver function | Liver function will be evaluated using the liver enzymes alanine aminotransferase and aspartate aminotransferase by the UV enzymatic kinetic method, as well as with alkaline phosphatase by the optimized kinetic method and direct bilirubin by the DMSO method (dimethyl sulfoxide-Malloy-Evelyn reaction). | Baseline to 8 weeks |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |