Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-26 @ 4:18 PM
Study NCT ID:
NCT01682694
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucosamine and Chondroitin Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D002807', 'term': 'Chondroitin'}], 'ancestors': [{'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-23', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hsCRP', 'timeFrame': '1 year', 'description': 'hsCRP is a biomarker of systemic inflammation'}], 'secondaryOutcomes': [{'measure': 'untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios)', 'timeFrame': '1 year', 'description': 'The mechanisms of action of glucosamine and chondroitin are currently unknown. Untargeted metabolomic assays of serum will be undertaken for exploratory analyses of potential effects of glucosamine and chondroitin. Significant differences in abundance ratios of small molecules between the intervention and placebo will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '25719429', 'type': 'DERIVED', 'citation': 'Navarro SL, White E, Kantor ED, Zhang Y, Rho J, Song X, Milne GL, Lampe PD, Lampe JW. Randomized trial of glucosamine and chondroitin supplementation on inflammation and oxidative stress biomarkers and plasma proteomics profiles in healthy humans. PLoS One. 2015 Feb 26;10(2):e0117534. doi: 10.1371/journal.pone.0117534. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.', 'detailedDescription': 'Use of glucosamine and chondroitin have been associated with reduced cancer and overall mortality. The aim of this study is to determine whether a common starting dose of glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic inflammation as reflected by a reduction in high sensitivity C-reactive protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Overweight (body mass index kg/m2 (BMI) between 25 and 32.5)\n* Non-smoking men and women\n* Aged 20-55y\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 \\> 30\n* Alcohol intake of greater than 2 drinks/day\n* Current use of prescription or over-the-counter medications, (Excluding oral contraceptives and hormone-secreting IUDs), including 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 4 months'}, 'identificationModule': {'nctId': 'NCT01682694', 'acronym': 'GLANCE', 'briefTitle': 'Glucosamine and Chondroitin Effects', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Glucosamine and Chondroitin Effects', 'orgStudyIdInfo': {'id': '7798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucosamine and Chondroitin', 'description': 'Glucosamine and Chondroitin', 'interventionNames': ['Dietary Supplement: Glucosamine and Chondroitin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inactive ingredients', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Glucosamine and Chondroitin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutramax'], 'description': 'Glucosamine (1500 mg) and Chondroitin (1200 mg)', 'armGroupLabels': ['Glucosamine and Chondroitin']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}