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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
University of Guanajuato
León, Guanajuato, Mexico
Degree of hepatic steatosis
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.
Time frame: Baseline to 8 weeks
Glucose
Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
Time frame: 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.
Time frame: Baseline to 8 weeks
Insulin resistance
The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.
Time frame: Baseline to 8 weeks
Lipid profile
The lipid profile will be measured by the modified Huang method of the Spinreact brand.
Time frame: Baseline to 8 weeks
LDL-cholesterol
LDL-cholesterol will be determined using the Friedwald formula.
Time frame: Baseline to 8 weeks
Urea levels
Urea levels will be obtained by the Urease GLDH kinetic method.
Time frame: Baseline to 8 weeks
Uric acid levels
Uric acid will be evaluated by peroxidase enzymes and colorimetry.
Time frame: 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).
Time frame: Baseline to 8 weeks
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