- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04871360
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
January 18, 2022 updated by: Ma Eugenia Garay Sevilla, Universidad de Guanajuato
Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guanajuato
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León, Guanajuato, Mexico, 37000
- University of Guanajuato
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Citrulline group
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.
|
The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
|
Placebo Comparator: Placebo group
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.
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The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose
Time Frame: Baseline to 8 weeks
|
Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
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Baseline to 8 weeks
|
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.
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Baseline to 8 weeks
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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.
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Baseline to 8 weeks
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Lipid profile
Time Frame: Baseline to 8 weeks
|
The lipid profile will be measured by the modified Huang method of the Spinreact brand.
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Baseline to 8 weeks
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LDL-cholesterol
Time Frame: Baseline to 8 weeks
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LDL-cholesterol will be determined using the Friedwald formula.
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Baseline to 8 weeks
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Urea levels
Time Frame: Baseline to 8 weeks
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Urea levels will be obtained by the Urease GLDH kinetic method.
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Baseline to 8 weeks
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Uric acid levels
Time Frame: Baseline to 8 weeks
|
Uric acid will be evaluated by peroxidase enzymes and colorimetry.
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Baseline to 8 weeks
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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).
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Baseline to 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ma. E Garay-Sevilla, PhD, Universidad de Guanajuato
- Study Chair: Verónica I Tovar-Villegass, Bachelor, Universidad de Guanajuato
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2021
Primary Completion (Actual)
December 19, 2021
Study Completion (Actual)
January 15, 2022
Study Registration Dates
First Submitted
April 25, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 4, 2021
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAFLD-CITRULLINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At the request of the researcher.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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