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| ID | Type | Description | Link |
|---|---|---|---|
| 2021A008958 | Other Identifier | MGB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocoa extract + multivitamin | Active Comparator |
| |
| Cocoa extract + multivitamin placebo | Active Comparator |
| |
| Cocoa extract placebo + multivitamin | Active Comparator |
| |
| Cocoa extract placebo + multivitamin placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa extract | Dietary Supplement | 2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine |
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| Measure | Description | Time Frame |
|---|---|---|
| Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) | 5 years | |
| Recurrent falls (2 or more falls per year) | 5 years |
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Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:
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| Name | Affiliation | Role |
|---|---|---|
| Meryl S LeBoff, MD | Brigham and Women's Hospital | Principal Investigator |
| Carolyn Crandall, MD, MS | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36621596 | Background | 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. |
| Label | URL |
|---|---|
| COSMOS Trial Website | View source |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000069956 | Chocolate |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Cocoa extract placebo | Dietary Supplement | Cocoa extract placebo |
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| Multivitamin | Dietary Supplement | Multivitamin |
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| Multivitamin placebo | Dietary Supplement | Multivitamin placebo |
|