Skip to main content
OpenTrials
Completed

NCT Number: NCT04871360

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guanajuato

León, Guanajuato, 37000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Citrulline supplement

Dietary Supplement

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

Carboxymethyl cellulose supplement

Dietary Supplement

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

Primary outcomes

  1. Degree of hepatic steatosis

    Time frame: Baseline to 8 weeks

    The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as:

    • Mild, when an increase in echogenicity and hepatomegaly are observed.
    • Moderate, when sound attenuation is added.
    • Severe, when the wall of the portal vessels and the diaphragm are not visible.

Secondary outcomes

  1. Glucose

    Time frame: Baseline to 8 weeks

    Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.

  2. Insulin

    Time frame: Baseline to 8 weeks

    The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.

  3. Insulin resistance

    Time frame: Baseline to 8 weeks

    The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.

  4. Lipid profile

    Time frame: Baseline to 8 weeks

    The lipid profile will be measured by the modified Huang method of the Spinreact brand.

  5. LDL-cholesterol

    Time frame: Baseline to 8 weeks

    LDL-cholesterol will be determined using the Friedwald formula.

  6. Urea levels

    Time frame: Baseline to 8 weeks

    Urea levels will be obtained by the Urease GLDH kinetic method.

  7. Uric acid levels

    Time frame: Baseline to 8 weeks

    Uric acid will be evaluated by peroxidase enzymes and colorimetry.

  8. Liver function

    Time frame: Baseline to 8 weeks

    Liver function will be evaluated using the liver enzymes alanine aminotransferase and aspartate aminotransferase by the UV enzymatic kinetic method, as well as with alkaline phosphatase by the optimized kinetic method and direct bilirubin by the DMSO method (dimethyl sulfoxide-Malloy-Evelyn reaction).

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Registry information

Official study title

Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease in Adolescents With Obesity

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 4, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.