Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity

Not Applicable

Completed

Interventions: Dietary Supplement: Carboxymethyl cellulose supplement
Dietary Supplement: L-Citrulline supplement

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Adolescents between 15 and 19 years old, residents of the city of León, Guanajuato, with obesity due to BMI ≥30 kg / m2 equivalent to the categorization of adults. That they are in stage 5 of Tanner scale with diagnosis of mild, moderate or severe NAFLD and / or alterations in liver enzyme levels. Not be under nutritional treatment, not be smokers, not taking multivitamins, if so, a wash time of 30 days will be given. Not be allergic to l-citrulline or watermelon. Alcohol consumption less than 21 standard drink units for men and 14 standard drink units for women per week (Standard drink: any drink with more than 14 g of pure alcohol).

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo group	Carboxymethyl cellulose supplement	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.
Citrulline group	L-Citrulline supplement	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.

Primary Outcome Measures

Name	Time	Method
Degree of hepatic steatosis	Baseline to 8 weeks	The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as: 1. Mild, when an increase in echogenicity and hepatomegaly are observed. 2. Moderate, when sound attenuation is added. 3. Severe, when the wall of the portal vessels and the diaphragm are not visible.

Secondary Outcome Measures

Name	Time	Method
Insulin	Baseline to 8 weeks	The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.
Insulin resistance	Baseline to 8 weeks	The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.
Glucose	Baseline to 8 weeks	Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
Lipid profile	Baseline to 8 weeks	The lipid profile will be measured by the modified Huang method of the Spinreact brand.
Urea levels	Baseline to 8 weeks	Urea levels will be obtained by the Urease GLDH kinetic method.
LDL-cholesterol	Baseline to 8 weeks	LDL-cholesterol will be determined using the Friedwald formula.
Uric acid levels	Baseline to 8 weeks	Uric acid will be evaluated by peroxidase enzymes and colorimetry.
Liver function	Baseline to 8 weeks	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).