Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT03985020
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2019-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of three possible groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Alanine Transaminase (ALT)', 'timeFrame': 'Week 1 to week 8 (IU/L)', 'description': 'A fasting blood sample will be taken at baseline and week 8 and assess change over time in all 3 groups'}], 'secondaryOutcomes': [{'measure': 'Change in Fat percentage', 'timeFrame': 'week 1 to 8 weeks (%)', 'description': 'Measured using DEXA'}, {'measure': 'Change in kPA levels', 'timeFrame': 'week 1 to 8 weeks (kPA)', 'description': 'Measured using MR elastography (non-sedated study)'}, {'measure': 'Change in Height', 'timeFrame': 'week 1 to 8 weeks (cm)', 'description': 'Height will be measured in duplicate within .5cm.'}, {'measure': 'Change in Weight', 'timeFrame': 'week 1 to 8 weeks (kg)', 'description': 'Measured using an electric scale.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'week 1 to 8 weeks (cm)', 'description': 'Hip-to-waist ratio will be calculated using a measuring tape that does not stretch, measuring twice at hip-level and twice at waist-level and averaging the results'}, {'measure': 'Change in Acanthosis nigricans skin exam', 'timeFrame': 'week 1 to 8 weeks', 'description': 'An Acanthosis Nigricans (AN) skin exam will be performed at each visit. Acanthosis Nigricans is an indicator for disorders of insulin resistance.'}, {'measure': 'Change in Triglyceride levels', 'timeFrame': 'week 1 to 8 weeks', 'description': 'measured by fasting blood sample'}, {'measure': 'Change in Glucose Level', 'timeFrame': 'Week 1 to week 8 (mg/dl)', 'description': 'Measured by fasting blood samples'}, {'measure': 'Change in Insulin Level', 'timeFrame': 'Week 1 to week 8 (UIU/mL)', 'description': 'Measured by fasting blood sample'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'In order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions:\n\n1. Standard of care\n2. Water delivery\n3. Water with Rebaudioside (stevia natural sweetener)', 'detailedDescription': "Rationale: Current treatment strategies for Nonalcoholic fatty liver disease, NAFLD, have focused on lifestyle management through a combination of diet and exercise but there are no recommendations for dietary changes that have been proven superior to others. Preliminary data showing an improvement in liver enzymes and fibrosis in mice has demonstrated a novel use of rebaudioside, the non-caloric sweetener (NCS) Stevia leaf's extract, potentially identifying this NCS as a therapeutic intervention where currently there are no targeted treatments.\n\nIntervention: All participants will receive standard of care for diet and nutrition. Additionally, participants will be randomized to one of four 8-week liquid diet interventions:\n\n1. Standard of Care\n2. Water Delivery\n3. Water with Rebaudioside (Stevia Natural Sweetener)\n\nObjectives and Purpose: To determine whether rebaudioside consumption can be used as a treatment for adolescents with NAFLD by demonstrating a decrease in ALT levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 10-18 years\n* ALT \\> 45 IU/L (twice the normal amount)\n* BMI \\>85%\n* Fat \\>5% and kPa\\> 2.7\n\nExclusion Criteria:\n\n* Physician diagnosis of a major medical illness including, but not limited to, chronic liver disease, immunodeficiency disorder, hypothalamic obesity, or a genetic cause of obesity.\n* Familial hyperlipidemia\n* Positive hepatitis lab\n* Antibiotics within 1 month of beginning the study\n* Physical, mental, or cognitive issues preventing participation\n* Pregnancy\n* Smoking or drinking'}, 'identificationModule': {'nctId': 'NCT03985020', 'briefTitle': 'Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis', 'orgStudyIdInfo': {'id': 'CHLA-19-00212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'The control group will receive standard of care dietary advice for their solid food and beverage intake.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Water Intervention', 'description': 'We will order and deliver bottled water to the homes of subjects in the treatment group. We will provide each participant with a weekly supply of about 36 16.9 fl oz single-serving containers. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously.', 'interventionNames': ['Other: Water Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Stevia Intervention', 'description': 'We will order and deliver a commercially-available stevia-sweetened soft drink Zevia (Los Angeles, CA) to each participant in the treatment group. We will provide each participant with a weekly supply of 24 12 fl oz single-serving containers. Zevia will be provided in an assortment of flavors for the first week, then catered to the preference of the participant for the remainder of the study. We will instruct subjects to notify us by calling a dedicated telephone line on occasions when a delivery is expected but not received so that the problem can be corrected expeditiously. Participants will also be asked to keep track of how many containers they consume using a sticker chart, and we will also phone parents weekly to verify the sticker charts', 'interventionNames': ['Other: Stevia Intervention']}], 'interventions': [{'name': 'Stevia Intervention', 'type': 'OTHER', 'description': 'We will use commercially available stevia sweetened soft drink Zevia.', 'armGroupLabels': ['Stevia Intervention']}, {'name': 'Water Intervention', 'type': 'OTHER', 'description': 'Bottled Water', 'armGroupLabels': ['Water Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Tania Mitsinikos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}, {'name': 'Rohit Kohli, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Staff/USC Faculty CWR', 'investigatorFullName': 'Tania Mitsinikos', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}