Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 12:33 AM
Study NCT ID:
NCT04496895
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2020-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'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': '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of body fat mass', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'The body fat mass (kg) was assessed by InBody770'}, {'measure': 'The change of Triglyceride', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of Triglyceride'}, {'measure': 'The change of Total cholestrol', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of Total cholestrol'}, {'measure': 'The change of HDL-cholestrol', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of HDL-cholestrol'}, {'measure': 'The change of LDL-cholestrol', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of LDL-cholestrol'}, {'measure': 'The change of body mass index (BMI)', 'timeFrame': 'Weeks 0, 4 and 8', 'description': "BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\\^2) and body mass (kg) were assessed by InBody770."}, {'measure': 'The change of body fat percentage', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'The body fat percentage (%) was assessed by InBody770.'}, {'measure': 'The change of visceral fat', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'The visceral fat (10 cm\\^2) was assessed by InBody770.'}, {'measure': 'The change of fasting glycemia', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of fasting glycemia'}, {'measure': 'The change of aspartate aminotransferase', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of aspartate aminotransferase'}, {'measure': 'The change of alanine aminotransferase', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of alanine aminotransferase'}, {'measure': 'The change of albumin', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of creatine'}, {'measure': 'The change of creatine', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of creatine'}, {'measure': 'The change of uric acid', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of uric acid'}, {'measure': 'The change of white blood cell', 'timeFrame': 'Weeks 0, 4 and 8', 'description': 'Venous blood was sampled to measure concentrations of white blood cell'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'To assess whether orange peel fermentation has the effect of reducing body fat in adults', 'detailedDescription': 'This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of overweight or fatty liver is evaluated by the doctor. The questionnaires are collected at every visit of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.\n2. For those with BMI ≥ 24 or fatty liver, male body fat ≥ 25%, female body fat ≥ 30%.\n3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.\n4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).\n\nExclusion Criteria:\n\n1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).\n2. No person who has received major surgery or bariatric surgery (according to medical history).\n3. I have used drugs that affect body fat, waist circumference or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability in the current or 3 months before participating in the screening Drugs (according to medical history).'}, 'identificationModule': {'nctId': 'NCT04496895', 'briefTitle': 'The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults', 'orgStudyIdInfo': {'id': '201912030RSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'consume 1 sachet per day for 2 months', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'orange peel fermentation', 'description': 'consume 1 sachet per day for 2 months', 'interventionNames': ['Dietary Supplement: orange peel fermentation']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 sachet per day for 2 months', 'armGroupLabels': ['Placebo']}, {'name': 'orange peel fermentation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 sachet per day for 2 months', 'armGroupLabels': ['orange peel fermentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'chi fu chiang, Ph.D', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'HUANG YU-JYUN', 'role': 'CONTACT', 'email': 'nneder34@gmail.com', 'phone': '0934173838'}], 'overallOfficials': [{'name': 'LIOU JYH-MING, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}