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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Citrulline group

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.

Group Type EXPERIMENTAL

L-Citrulline supplement

Intervention Type DIETARY_SUPPLEMENT

The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Carboxymethyl cellulose supplement

Intervention Type DIETARY_SUPPLEMENT

The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.

Interventions

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L-Citrulline supplement

The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.

Intervention Type DIETARY_SUPPLEMENT

Carboxymethyl cellulose supplement

The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No