Non-Alcoholic Fatty Liver DiseaseNCT04871360
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
A study testing L-Citrulline supplement and Carboxymethyl cellulose supplement in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Universidad de Guanajuato at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- L-Citrulline supplement and Carboxymethyl cellulose supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 5 May 2021to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- L-Citrulline supplement, Carboxymethyl cellulose supplement
- Keywords
- NAFLD, Obesity, Adolescents, L-citrulline supplementation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Citrulline supplementDietary supplement
The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
Carboxymethyl cellulose supplementDietary supplement
The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Carboxymethyl cellulose supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Glucose
Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.
Measured: Baseline to 8 weeks
Insulin
The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.
Measured: Baseline to 8 weeks
Insulin resistance
The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.
Measured: Baseline to 8 weeks
Lipid profile
The lipid profile will be measured by the modified Huang method of the Spinreact brand.
Measured: Baseline to 8 weeks
LDL-cholesterol
LDL-cholesterol will be determined using the Friedwald formula.
Measured: Baseline to 8 weeks
Urea levels
Urea levels will be obtained by the Urease GLDH kinetic method.
Measured: Baseline to 8 weeks
Uric acid levels
Uric acid will be evaluated by peroxidase enzymes and colorimetry.
Measured: Baseline to 8 weeks
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).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start5 May 2021
- Primary completion19 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Eugenia Garay Sevilla, Universidad de Guanajuato
- Investigators
- Ma. E Garay-Sevilla, PhD, Principal investigator, Universidad de GuanajuatoVerónica I Tovar-Villegass, Bachelor, Study chair, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871360
- Sponsor's protocol ID
- NAFLD-CITRULLINE
- Status last verified
- Jan 2022
- First submitted
- 25 Apr 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the request of the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT04871360
- Acronym / sponsor ID
- NAFLD-CITRULLINE
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Keywords
- NAFLD, Obesity, Adolescents, L-citrulline supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Citrulline group | Experimental | Dietary Supplement: L-Citrulline supplementGroup 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. |
| Placebo group | Placebo comparator | Dietary Supplement: Carboxymethyl cellulose supplementGroup 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. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Citrulline supplementThe intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks. | Dietary supplement | Citrulline group |
| Carboxymethyl cellulose supplementThe intervention will consist of oral carboxymethyl cellulose supplementation as a placebo. | Dietary supplement | Placebo group |
Primary outcome
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: 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.
8 secondary outcomes
Glucose
Time frame: Baseline to 8 weeks
Insulin
Time frame: Baseline to 8 weeks
Insulin resistance
Time frame: Baseline to 8 weeks
Lipid profile
Time frame: Baseline to 8 weeks
LDL-cholesterol
Time frame: Baseline to 8 weeks
Urea levels
Time frame: Baseline to 8 weeks
Uric acid levels
Time frame: Baseline to 8 weeks
Liver function
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No. At the request of the researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ma. E Garay-Sevilla, PhD principal investigator
Universidad de Guanajuato
Verónica I Tovar-Villegass, Bachelor study chair
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Citrulline supplement and Carboxymethyl cellulose supplement in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Universidad de Guanajuato at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of hepatic steatosis (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.