Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-30 @ 7:57 PM
Study NCT ID:
NCT05232669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069956', 'term': 'Chocolate'}, {'id': 'C067316', 'term': 'Geritol'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21442}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-01-31', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)', 'timeFrame': '5 years'}, {'measure': 'Recurrent falls (2 or more falls per year)', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fall', 'Physical Performance', 'Fracture']}, 'referencesModule': {'references': [{'pmid': '36621596', 'type': 'BACKGROUND', 'citation': 'LeBoff MS, Chou SH, Ratliff KA, Cook NR, Clar A, Holman B, Copeland T, Smith DC, Rist PM, Manson JE, Sesso HD, Crandall CJ. Rationale and design of an ancillary study evaluating the effects of the cocoa flavanol and/or multivitamin interventions on falls and physical performance outcomes in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Contemp Clin Trials. 2023 Feb;125:107078. doi: 10.1016/j.cct.2023.107078. Epub 2023 Jan 6.'}], 'seeAlsoLinks': [{'url': 'http://www.cosmostrial.org/', 'label': 'COSMOS Trial Website'}]}, 'descriptionModule': {'briefSummary': 'The COcoa Supplement and Multivitamin Outcomes Study (COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improve musculoskeletal health and prevent falls and declining physical performance in the increasing number of older adults in the U.S. with potential for clinical and public health benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:\n\n1. Participants who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)\n2. Participants who reported recurrent falls (2 or more falls per year)'}, 'identificationModule': {'nctId': 'NCT05232669', 'acronym': 'COSMOS', 'briefTitle': 'COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance', 'orgStudyIdInfo': {'id': '2021P003714'}, 'secondaryIdInfos': [{'id': '2021A008958', 'type': 'OTHER', 'domain': 'MGB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cocoa extract + multivitamin', 'interventionNames': ['Dietary Supplement: Cocoa extract', 'Dietary Supplement: Multivitamin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cocoa extract + multivitamin placebo', 'interventionNames': ['Dietary Supplement: Cocoa extract', 'Dietary Supplement: Multivitamin placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cocoa extract placebo + multivitamin', 'interventionNames': ['Dietary Supplement: Cocoa extract placebo', 'Dietary Supplement: Multivitamin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cocoa extract placebo + multivitamin placebo', 'interventionNames': ['Dietary Supplement: Cocoa extract placebo', 'Dietary Supplement: Multivitamin placebo']}], 'interventions': [{'name': 'Cocoa extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine', 'armGroupLabels': ['Cocoa extract + multivitamin', 'Cocoa extract + multivitamin placebo']}, {'name': 'Cocoa extract placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cocoa extract placebo', 'armGroupLabels': ['Cocoa extract placebo + multivitamin', 'Cocoa extract placebo + multivitamin placebo']}, {'name': 'Multivitamin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multivitamin', 'armGroupLabels': ['Cocoa extract + multivitamin', 'Cocoa extract placebo + multivitamin']}, {'name': 'Multivitamin placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multivitamin placebo', 'armGroupLabels': ['Cocoa extract + multivitamin placebo', 'Cocoa extract placebo + multivitamin placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Meryl S LeBoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Carolyn Crandall, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Meryl LeBoff', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}