Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 7:54 AM
Study NCT ID:
NCT04871360
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The intervention consists of the oral administration of placebo or l-citrulline as follows:\n\nGroup 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.\n\nGroup 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of hepatic steatosis', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as:\n\n1. Mild, when an increase in echogenicity and hepatomegaly are observed.\n2. Moderate, when sound attenuation is added.\n3. Severe, when the wall of the portal vessels and the diaphragm are not visible.'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.'}, {'measure': 'Insulin', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.'}, {'measure': 'Insulin resistance', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.'}, {'measure': 'Lipid profile', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The lipid profile will be measured by the modified Huang method of the Spinreact brand.'}, {'measure': 'LDL-cholesterol', 'timeFrame': 'Baseline to 8 weeks', 'description': 'LDL-cholesterol will be determined using the Friedwald formula.'}, {'measure': 'Urea levels', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Urea levels will be obtained by the Urease GLDH kinetic method.'}, {'measure': 'Uric acid levels', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Uric acid will be evaluated by peroxidase enzymes and colorimetry.'}, {'measure': 'Liver function', 'timeFrame': 'Baseline to 8 weeks', '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAFLD', 'Obesity', 'Adolescents', 'L-citrulline supplementation'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* Present intolerance to l-citrulline or allergy to watermelon.\n* Have an adherence of less than 80 percent of the treatments.\n* Present other causes of liver disease.'}, 'identificationModule': {'nctId': 'NCT04871360', 'briefTitle': 'Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Guanajuato'}, 'officialTitle': 'Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease in Adolescents With Obesity', 'orgStudyIdInfo': {'id': 'NAFLD-CITRULLINE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citrulline group', '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.', 'interventionNames': ['Dietary Supplement: L-Citrulline supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', '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.', 'interventionNames': ['Dietary Supplement: Carboxymethyl cellulose supplement']}], 'interventions': [{'name': 'L-Citrulline supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.', 'armGroupLabels': ['Citrulline group']}, {'name': 'Carboxymethyl cellulose supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37000', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'University of Guanajuato', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}], 'overallOfficials': [{'name': 'Ma. E Garay-Sevilla, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Guanajuato'}, {'name': 'Verónica I Tovar-Villegass, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Guanajuato'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At the request of the researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Guanajuato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Titular Research Professor', 'investigatorFullName': 'Ma Eugenia Garay Sevilla', 'investigatorAffiliation': 'Universidad de Guanajuato'}}}}