FallCOSMOSNCT05232669
COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance
A study testing Cocoa extract and Multivitamin in people with Fall and Physical Performance, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Physical Performance, Fracture
- What is being tested?
- Cocoa extract and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21,442 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:
- Participants who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)
- Participants who reported recurrent falls (2 or more falls per year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
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.
- Conditions
- Fall, Physical Performance, Fracture
- Being tested
- Cocoa extract, Cocoa extract placebo, Multivitamin, Multivitamin placebo
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa extractDietary supplement
2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
Cocoa extract placeboDietary supplement
Cocoa extract placebo
MultivitaminDietary supplement
Multivitamin
Multivitamin placeboDietary supplement
Multivitamin placebo
| Study group | Role | What they receive |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Not described Receives: Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Not described Receives: Dietary Supplement: Cocoa extract; Dietary Supplement: Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Not described Receives: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Not described Receives: Dietary Supplement: Cocoa extract placebo; Dietary Supplement: Multivitamin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
Measured: 5 years
Recurrent falls (2 or more falls per year)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start15 May 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryl LeBoff, Brigham and Women's Hospital
- Investigators
- Meryl S LeBoff, MD, Principal investigator, Brigham and Women's HospitalCarolyn Crandall, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232669
- Sponsor's protocol ID
- 2021P003714
- Other IDs
- 2021A008958
- Acronym
- COSMOS
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36621596
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COcoa Supplement and Multivitamin Outcomes Study (COSMOS): Effects on Falls and Physical Performance
- ClinicalTrials.gov ID
- NCT05232669
- Acronym / sponsor ID
- COSMOS / 2021P003714
- Conditions
- Fall, Physical Performance, Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21,442 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cocoa extract + multivitamin | Active comparator | Dietary Supplement: Cocoa extract, Dietary Supplement: Multivitamin |
| Cocoa extract + multivitamin placebo | Active comparator | Dietary Supplement: Cocoa extract, Dietary Supplement: Multivitamin placebo |
| Cocoa extract placebo + multivitamin | Active comparator | Dietary Supplement: Cocoa extract placebo, Dietary Supplement: Multivitamin |
| Cocoa extract placebo + multivitamin placebo | Placebo comparator | Dietary Supplement: Cocoa extract placebo, Dietary Supplement: Multivitamin placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa extract2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract + multivitamin placebo |
| Cocoa extract placeboCocoa extract placebo | Dietary supplement | Cocoa extract placebo + multivitamin, Cocoa extract placebo + multivitamin placebo |
| MultivitaminMultivitamin | Dietary supplement | Cocoa extract + multivitamin, Cocoa extract placebo + multivitamin |
| Multivitamin placeboMultivitamin placebo | Dietary supplement | Cocoa extract + multivitamin placebo, Cocoa extract placebo + multivitamin placebo |
Primary outcome
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)
Time frame: 5 years
Recurrent falls (2 or more falls per year)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 36621596LeBoff 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.
- COSMOS Trial WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryl S LeBoff, MD principal investigator
Brigham and Women's Hospital
Carolyn Crandall, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa extract and Multivitamin in people with Fall and Physical Performance, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.