Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT06283732
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Digestive Health Improvement', 'timeFrame': '14 days from the start of intervention', 'description': 'Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).'}], 'secondaryOutcomes': [{'measure': 'Quality of Life and Well-being Enhancement', 'timeFrame': '14 days from the start of intervention', 'description': "Assess improvements in participants' quality of life, energy levels, satiety, and overall well-being through validated questionnaires."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary Supplements', 'Digestive Health', 'Well-being', 'Energy Levels'], 'conditions': ['Digestive System Disease']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female.\n* Aged 18-65 years.\n* Willing to comply with study requirements.\n* No known allergies to the ingredients listed in the product.\n* Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).\n* Generally healthy - do not live with any uncontrolled chronic disease .\n\nExclusion Criteria:\n\n* Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.\n* Known severe allergic reactions that require an Epi-Pen.\n* Women who are pregnant, breastfeeding, or attempting to conceive.\n* History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.\n* Unwillingness to follow the study protocol.\n* Invasive medical procedure within the last three weeks or planning one during the study period.\n* History of substance abuse.\n* Current participation or planning to participate in another research study.\n* Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.\n* Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) ."}, 'identificationModule': {'nctId': 'NCT06283732', 'briefTitle': 'A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amway Corp'}, 'officialTitle': 'A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.', 'orgStudyIdInfo': {'id': '20392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dietary Supplement: Greens powder', 'description': 'Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.', 'interventionNames': ['Dietary Supplement: Greens powder']}], 'interventions': [{'name': 'Greens powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.', 'armGroupLabels': ['Dietary Supplement: Greens powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amway Corp', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}