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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
L-Citrulline supplement
Carboxymethyl cellulose supplement
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, Obesity, Adolescents, L-citrulline supplementation

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Guanajuato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citrulline group

Placebo group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Degree of hepatic steatosis
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 Outcome Measures

Glucose
Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
Insulin
The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.
Insulin resistance
The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.
Lipid profile
The lipid profile will be measured by the modified Huang method of the Spinreact brand.
LDL-cholesterol
LDL-cholesterol will be determined using the Friedwald formula.
Urea levels
Urea levels will be obtained by the Urease GLDH kinetic method.
Uric acid levels
Uric acid will be evaluated by peroxidase enzymes and colorimetry.
Liver function
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).

Full Information

First Posted
April 25, 2021
Last Updated
January 18, 2022
Sponsor
Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT04871360
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
December 19, 2021 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Guanajuato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Obesity
Keywords
NAFLD, Obesity, Adolescents, L-citrulline supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrulline group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Citrulline supplement
Intervention Description
The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carboxymethyl cellulose supplement
Intervention Description
The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
Primary Outcome Measure Information:
Title
Degree of hepatic steatosis
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Glucose
Description
Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
Time Frame
Baseline to 8 weeks
Title
Insulin
Description
The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.
Time Frame
Baseline to 8 weeks
Title
Insulin resistance
Description
The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.
Time Frame
Baseline to 8 weeks
Title
Lipid profile
Description
The lipid profile will be measured by the modified Huang method of the Spinreact brand.
Time Frame
Baseline to 8 weeks
Title
LDL-cholesterol
Description
LDL-cholesterol will be determined using the Friedwald formula.
Time Frame
Baseline to 8 weeks
Title
Urea levels
Description
Urea levels will be obtained by the Urease GLDH kinetic method.
Time Frame
Baseline to 8 weeks
Title
Uric acid levels
Description
Uric acid will be evaluated by peroxidase enzymes and colorimetry.
Time Frame
Baseline to 8 weeks
Title
Liver function
Description
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).
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma. E Garay-Sevilla, PhD
Organizational Affiliation
Universidad de Guanajuato
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Verónica I Tovar-Villegass, Bachelor
Organizational Affiliation
Universidad de Guanajuato
Official's Role
Study Chair
Facility Information:
Facility Name
University of Guanajuato
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At the request of the researcher.

Learn more about this trial

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

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