Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT07231003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Glucomannan Powder on Improving Gut Microbiota.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022901', 'term': '(1-6)-alpha-glucomannan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gut microbiota', 'timeFrame': 'Week(0) (Baseline), Wk(6),Wk7', 'description': 'Evaluation of Gut Microbiota by Analysis of Four Indicator Strains and 16S rRNA Sequencing Using Fecal Samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysbiosis', 'Glucomannan', 'gut-microbiota'], 'conditions': ['Dysbiosis']}, 'descriptionModule': {'briefSummary': 'The object of this study is evaluating the effects of the Glucommanan on the healthy human subjects who are. In this trial, at most 30 healthy subjects whose ages are 20\\~65 years old (15 for placebo and 15 for intervention)will be included. The total experiment will be 9 weeks and the intervention period will be 6 weeks, within which, at week 0, 6, and 7, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), aspartate aminotransferase (AST, also known as GOT), alanine aminotransferase (ALT, also known as GPT), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood glucose (Glucose, AC) and adiponectin would be measured. Feces samples and anthropometric data will also be acquired. The results will be analyzed according to the methods published by the Ministry of Health and Welfare of Taiwan Food and Drug Administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Both genders, aged between 20 and 65 years.\n\nNo history of gastrointestinal disorders or other significant health issues.\n\nOverall good health.\n\nExclusion Criteria:\n\n\\- Participants who have taken antibiotics or any medications/supplements that could affect the gut microbiota within 1 week prior to the experiment or during the study.\n\nPregnant or breastfeeding women.\n\nSmokers or individuals with excessive alcohol consumption.\n\nChronic disease medication usage for less than 3 months.\n\nPostmenopausal women on hormone replacement therapy.\n\nIndividuals with acute illnesses such as a cold.'}, 'identificationModule': {'nctId': 'NCT07231003', 'briefTitle': 'The Effect of Glucomannan Powder on Improving Gut Microbiota.', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'The Effect of Glucomannan Powder on Improving Gut Microbiota.', 'orgStudyIdInfo': {'id': 'lin5611_03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '2 packs of corn starch daily', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '2 packs of glucomannan powder daily', 'interventionNames': ['Dietary Supplement: Glucomannan']}], 'interventions': [{'name': 'Glucomannan', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 packs of glucomannan, 2 grams per pack', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 packs of corn starch, 2 grams per pack', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}