Clinical trial NCT04871360: Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
Official title: Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Obesity
Keywords: NAFLD
Obesity
Adolescents
L-citrulline supplementation
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of hepatic steatosis
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Glucose
timeFrame: Baseline to 8 weeks
measure: Insulin
timeFrame: Baseline to 8 weeks
measure: Insulin resistance
timeFrame: Baseline to 8 weeks
measure: Lipid profile
timeFrame: Baseline to 8 weeks
measure: LDL-cholesterol
timeFrame: Baseline to 8 weeks
measure: Urea levels
timeFrame: Baseline to 8 weeks
measure: Uric acid levels
timeFrame: Baseline to 8 weeks
measure: Liver function
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: León
country: Mexico
facility: University of Guanajuato
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Ma. E Garay-Sevilla, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Guanajuato
name: Verónica I Tovar-Villegass, Bachelor
role: STUDY_CHAIR
References: