Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
Study NCT ID:
NCT03827161
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2019-01-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005944', 'term': 'Glucosamine'}], 'ancestors': [{'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of glucosamine sulfate/chondroitin sulfate tablet (G&C) on gut microbial community modulation', 'timeFrame': 'Up to 2 years', 'description': 'shifts in the bacterial communities within person based on clustering of operational taxonomic units (OTU) at 97% utilizing principal coordinate analysis \\[PCOA\\]).'}, {'measure': 'Effects of G&C on serum C-reactive protein (CRP)', 'timeFrame': 'Up to 2 years', 'description': 'evaluated using a generalized estimating equation which accounts for variation due to repeated measures within an individual'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subject', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. Chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. Glucosamine and chondroitin may prevent inflammation and this trial may help identify the bacteria that help process them in the gut.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Individuals from the Greater Seattle area who are overweight (body mass index \\[BMI\\] of 25-32.5 kg/m\\^2)\n\nExclusion Criteria:\n\n* Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)\n* Pregnancy or lactation\n* Currently on a weight-loss diet\n* BMI (body mass index) \\< 25 or \\> 32.5 kg/m\\^2\n* Alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits)\n* Current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (IUD)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), or use of aspirin or NSAIDs more than 2 days per week\n* Abnormal renal, liver or metabolic test\n* Inability to swallow pills\n* Known allergy to shellfish\n* Not willing to take pills made from shellfish or animal sources\n* Intention to relocate out of study area within next 2 months\n* Any antibiotic use in the past 6 months'}, 'identificationModule': {'nctId': 'NCT03827161', 'briefTitle': 'Glucosamine and Chondroitin in Preventing Inflammation in Overweight Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'GLANCE 2 - Glucosamine and Chondroitin (G&C) Effects Study', 'orgStudyIdInfo': {'id': 'RG1001578'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02647', 'type': 'OTHER', 'domain': 'CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (glucosamine sulfate/chondroitin sulfate tablet)', 'description': 'Patients receive glucosamine sulfate/chondroitin sulfate tablet PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm II.', 'interventionNames': ['Dietary Supplement: Glucosamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Patients receive placebo PO on days 1-14 in the absence of disease progression or unacceptable toxicity. Fourteen days later, patients crossover to Arm I.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Glucosamine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given PO', 'armGroupLabels': ['Arm I (glucosamine sulfate/chondroitin sulfate tablet)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Johanna Lampe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}