Clinical trial · Interventional
COcoa Supplement and Multivitamin Outcomes Study
NCT02422745CI-TRIAL-00117725COSMOScompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether taking daily, dietary supplements of cocoa extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard multivitamin reduces the risk of developing cardiovascular disease (including heart attack, stroke, coronary revascularization, unstable angina or acute coronary syndrome (ACS) requiring hospitalization, carotid artery surgery, and peripheral artery surgery or angioplasty, and cardiovascular mortality) and cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Disease | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cocoa extract | Dietary Supplement | — | UNRESOLVED |
| Cocoa extract placebo | Dietary Supplement | — | UNRESOLVED |
| Multivitamin | Dietary Supplement | — | UNRESOLVED |
| Multivitamin placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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: Multivitamin
- Dietary Supplement: Cocoa extract placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women ≥ 65 years of age participating in the Women's Health Initiative (WHI) Extension Study. 2. Men ≥ 60 years of age and women age ≥ 65 years of age who were contacted for but not randomized into the VITAL trial. 3. Other women ≥ 65 years of age and men aged ≥ 60 years of age who responded to targeted mass mailings and volunteers who learned about the trial through the media or through ResearchMatch.org, an electronic recruitment website. 4. Willing to participate, as evidenced by providing informed consent and completing all required baseline forms. Exclusion Criteria: 1. History of myocardial infarction or stroke. 2. Diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to enrollment. 3. Any serious illness that would preclude participation and/or completion of the trial, including the diagnosis of kidney failure and current dialysis treatment. 4. Taking cocoa extract or multivitamin supplements and not willing to forego use during the trial. 5. Taking total supplemental vitamin D \> 1,000 IU/day and not willing to forego use during the trial. 6. Taking total supplemental calcium \> 1,200 mg/day and not willing to forego use during the trial. 7. Extreme sensitivity to caffeine. 8. Consume \< 75% of the expected number of both types of supplements during the run-in phase. 9. Unable to communicate in English due to language barrier or mental incapacity.
References
Publications (9)
- DERIVEDLi J, Manson JE, Rist PM, Clar A, Moorthy MV, Kim E, Sarkissian A, Sesso HD. Multivitamin supplementation and COVID-19 incidence and symptom severity in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized trial. Am J Clin Nutr. 2026 Jul;124(1):101355. doi: 10.1016/j.ajcnut.2026.101355. Epub 2026 Jun 9. PMID 42385272
- DERIVEDLi S, Hamaya R, Farukhi Z, Li J, Rist PM, Manson JE, Sesso HD. Effects of daily multivitamin-multimineral supplementation on metabolomic profiles: 2-year findings from the COSMOS randomized clinical trial. Geroscience. 2026 Mar 30. doi: 10.1007/s11357-026-02197-9. Online ahead of print. PMID 41910928
- DERIVEDHamaya R, Li S, Lau J, Rautiainen S, Haring B, Liu S, Shadyab AH, Martin LW, Wassertheil-Smoller S, Rist PM, Manson JE, Sesso HD; COSMOS Research Group. Long-Term Effect of Multivitamin Supplementation on Incident Self-Reported Hypertension and Blood Pressure Changes in the COSMOS Trial. Am J Hypertens. 2026 Apr 1;39(4):538-546. doi: 10.1093/ajh/hpaf224. PMID 41264477
- DERIVEDVyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18. PMID 38244989
- DERIVEDVyas CM, Manson JE, Sesso HD, Rist PM, Weinberg A, Kim E, Moorthy MV, Cook NR, Okereke OI. Effect of cocoa extract supplementation on cognitive function: results from the clinic subcohort of the COSMOS trial. Am J Clin Nutr. 2024 Jan;119(1):39-48. doi: 10.1016/j.ajcnut.2023.10.031. Epub 2023 Dec 7. PMID 38070683
- DERIVEDSesso HD, Rist PM, Aragaki AK, Rautiainen S, Johnson LG, Friedenberg G, Copeland T, Clar A, Mora S, Moorthy MV, Sarkissian A, Wactawski-Wende J, Tinker LF, Carrick WR, Anderson GL, Manson JE; COSMOS Research Group. Multivitamins in the prevention of cancer and cardiovascular disease: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial. Am J Clin Nutr. 2022 Jun 7;115(6):1501-1510. doi: 10.1093/ajcn/nqac056.