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

NCT04871360 | Completed

• 1 other identifier: NAFLD-CITRULLINE
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Obesity

Keywords

NAFLD; Obesity; Adolescents; L-citrulline supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Glucose

  Baseline to 8 weeks

• Insulin

  Baseline to 8 weeks

• Insulin resistance

  Baseline to 8 weeks

• Lipid profile

  Baseline to 8 weeks

• LDL-cholesterol

  Baseline to 8 weeks

Study Arms (2)

Citrulline group

EXPERIMENTAL

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.

Dietary Supplement: L-Citrulline supplement

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Carboxymethyl cellulose supplement

Interventions

L-Citrulline supplement DIETARY_SUPPLEMENT

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

Citrulline group

Carboxymethyl cellulose supplement DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37000, Mexico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ma. E Garay-Sevilla, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

• Verónica I Tovar-Villegass, Bachelor

  Universidad de Guanajuato

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Research Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 4, 2021
• Study Start: May 5, 2021
• Primary Completion: December 19, 2021
• Study Completion: January 15, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)