Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT04492605
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', '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.'}], 'secondaryOutcomes': [{'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 albumin'}, {'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': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults', 'detailedDescription': 'This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 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. BMI ≥ 24 or 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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).\n2. No person who has undergone major surgery or bariatric surgery (according to medical history).\n3. Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).'}, 'identificationModule': {'nctId': 'NCT04492605', 'briefTitle': 'The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults', 'orgStudyIdInfo': {'id': '201912029RSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'TCI378 Probiotics', 'description': 'TCI378 Probiotics', 'interventionNames': ['Dietary Supplement: TCI378 Probiotics']}, {'type': 'EXPERIMENTAL', 'label': 'TCI507 Probiotics', 'description': 'TCI507 Probiotics', 'interventionNames': ['Dietary Supplement: TCI507 Probiotics']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 capsule per day for 2 months', 'armGroupLabels': ['Placebo']}, {'name': 'TCI378 Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 capsule per day for 2 months', 'armGroupLabels': ['TCI378 Probiotics']}, {'name': 'TCI507 Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'consume 1 capsule per day for 2 months', 'armGroupLabels': ['TCI507 Probiotics']}]}, '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}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'chi fu chiang, phd', 'role': 'CONTACT', 'email': 'Jimmy.Chiang@tci-bio.com'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hung YU-JUN', 'role': 'CONTACT', 'email': 'nneder34@gmail.com', 'phone': '0934173838'}], 'overallOfficials': [{'name': 'LIOU JYH-MING', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}