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

Universidad de Guanajuato

Status: Completed

Conditions: Obesity; Non-Alcoholic Fatty Liver Disease

Treatments: Dietary Supplement: Carboxymethyl cellulose supplement; Dietary Supplement: L-Citrulline supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04871360

NAFLD-CITRULLINE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No Healthy Volunteers

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

• Present intolerance to l-citrulline or allergy to watermelon.
• Have an adherence of less than 80 percent of the treatments.
• Present other causes of liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Citrulline group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: L-Citrulline supplement

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Carboxymethyl cellulose supplement