Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Alcoholic Fatty Liver Disease
- Obesity
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 19 years
- Gender
- Both males and females
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. ...
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.
Tracking Information
- NCT #
- NCT04871360
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ma. E Garay-Sevilla, PhD Universidad de Guanajuato Study Chair: Verónica I Tovar-Villegass, Bachelor Universidad de Guanajuato
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