Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT04575506
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2020-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
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'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-09-29', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic fat', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program'}, {'measure': 'Intestinal microbiota', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Diversity and composition of intestinal microbiota before and after 12-weeks intervention program'}, {'measure': 'Salivary microbiota', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Diversity and composition of salivary microbiota before and after 12-weeks intervention program'}], 'secondaryOutcomes': [{'measure': 'Visceral adiposity', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program'}, {'measure': 'Subcutaneous abdominal adiposity', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Subcutaneous abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program'}, {'measure': 'Intermuscular abdominal adiposity', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Intermuscular abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program'}, {'measure': 'Weight', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Weight measured by bioimpedance before and after 12-weeks intervention program'}, {'measure': 'Height', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Height measured by stadiometer before and after 12-weeks intervention program'}, {'measure': 'Fat mass', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Fat mass measured by bioimpedance before and after 12-weeks intervention program'}, {'measure': 'Fat-free mass', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Fat free mass measured by bioimpedance before and after 12-weeks intervention program'}, {'measure': 'Glucose', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Glucose measured by blood analysis before and after 12-weeks intervention program'}, {'measure': 'Insulin', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Serum insulin concentration measured by ELISA before and after 12-weeks intervention program'}, {'measure': 'Cholesterol', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program'}, {'measure': 'Triglycerides', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program'}, {'measure': 'Leptin', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program'}, {'measure': 'Adiponectin', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Plasma adiponectin measured by ELISA before and after 12-weeks intervention program'}, {'measure': 'C-reactive protein', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program'}, {'measure': 'Waist circumference', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Waist circumference measured by non-elastic tape before and after 12-weeks intervention program'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program'}, {'measure': 'Physical fitness', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.'}, {'measure': 'Physical activity and sleep', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program'}, {'measure': '24h dietary habits', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': '24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program'}, {'measure': 'Dietary habits history', 'timeFrame': 'baseline and post-test (12-weeks)', 'description': 'Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-alcoholic hepatic steatosis', 'Obesity', 'Children', 'Exercise', 'Diet', 'Microbiota'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)', 'detailedDescription': 'The MicroKid project will acts first as a case-control study (Study I) in order to identify the hepatic steatosis and intestinal and salivary microbiota in children grouped as non-overweight, obese-non-hepatic steatosis, and obese-hepatic steatosis. Then, an intervention study (Study II) will be developed for those children with obesity (i.e., obese-non-hepatic steatosis, and obese-hepatic steatosis groups).\n\nMethodology: A total of 60 children, 8-12 years-old, will be assigned to control (non-overweight children, N= 20), obese-non-hepatic steatosis (children with obesity, but without hepatic steatosis, N=20), and obese-hepatic steatosis (children with obesity and hepatic steatosis, N= 20) groups (Study I: case-control study). The obesity and obesity + hepatic steatosis groups will attend to a 12-weeks healthy lifestyle education program (2 days/month) and home-based exercise program (minimum 3 days/week) (Study II: intervention study).\n\nThe combined intervention program for the Study II will include: i) healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and ii) exercise program based on high-intensity interval training which combines aerobic and resistance training (at least 3 days/week, from 38 to 44 min).\n\nMeasurements: In the Study I (i.e., case-control study), all participants will be evaluated at baseline. For the Study II (i.e., intervention study), only those participants that belongs to obese-non-hepatic steatosis and obese-hepatic steatosis groups, will be additionally evaluated after the intervention program (12-week). The following outcomes will be measured: hepatic fat fraction and abdominal adiposity (magnetic resonance imaging), intestinal and salivary microbiota, body composition (bioimpedance), cardiometabolic risk factors, liver enzymes, physical fitness (field-fitness tests), physical activity (accelerometry), sleep (accelerometry), dietary habits (24h recalls, and food frequency questionnaires), and pubertal development and sociodemographic characteristics will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity defined based on the sex-and-age specific body mass index standards\n* 8-12 years old\n\nExclusion Criteria:\n\n* Medical conditions that hamper their participation in the exercise program'}, 'identificationModule': {'nctId': 'NCT04575506', 'acronym': 'MicroKid', 'briefTitle': 'Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Pública de Navarra'}, 'officialTitle': 'Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver: Identification of Biomarkers and Development of Personalized Therapy: The MicroKid Project', 'orgStudyIdInfo': {'id': 'PI_2020/29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obesity-Non-hepatic steatosis', 'description': 'Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min).', 'interventionNames': ['Other: Multidisciplinary intervention program']}, {'type': 'EXPERIMENTAL', 'label': 'Obesity-Hepatic steatosis', 'description': 'Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min).', 'interventionNames': ['Other: Multidisciplinary intervention program']}], 'interventions': [{'name': 'Multidisciplinary intervention program', 'type': 'OTHER', 'description': 'The intervention program includes an educational program promoting healthy dietary habits and physical activity (nutritionist and exercise physiologist) (2 times/month, for children and parents), and supervised home-based exercise (from 3 to 5 times/week, 38-44 min) program for 12-weeks.', 'armGroupLabels': ['Obesity-Hepatic steatosis', 'Obesity-Non-hepatic steatosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pamplona', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Pamplona', 'country': 'Spain', 'facility': 'Public University of Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Pública de Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complejo Hospitalario de Navarra', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}