# COcoa Supplement and Multivitamins Outcomes Study (COSMOS): Effects on Falls and Physical Performance

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $670,395

## Abstract

ABSTRACT
Falls and decreased physical function increase markedly with age and result in injury, hospitalization, and
death. Safe, cost-effective primary prevention strategies are needed to reduce these adverse outcomes in the
aging U.S. population. Basic, preclinical, and clinical studies suggest that flavanols, a class of nutrients present
in high concentrations in cocoa, have favorable effects on muscle and physical performance. Flavanols
decrease oxidative stress and improve biomarkers of mitochondrial biogenesis and muscle growth. Emerging
studies show potential benefits of supplemental cocoa flavanols on physical performance, including grip
strength and walking speed in older adults. However, there are no large, long-term randomized controlled trials
(RCTs) of the effects of supplemental flavanols on falls, muscle performance, and/or fall-related injuries. In an
ancillary study to the COcoa Supplement and Multivitamins Outcomes Study (COSMOS), which is testing the
effects of supplemental cocoa flavanols and/or multivitamin for the prevention of cardiovascular disease and
cancer, we propose the first large, placebo-controlled, prospective study to determine whether supplemental
flavanols reduce falls and improve musculoskeletal health in women aged ≥ 65 and men aged ≥ 60. In the
proposed study, we will determine effects of a cocoa flavanol supplement [600 mg/d flavanols, including 80 mg
(-)- epicatechins] and/or multivitamin on the following clinically meaningful outcomes: falls in the overall
COSMOS cohort (n=21,444) and physical performance in a clinic sub-cohort (n=603). We will test the following
hypotheses: Aim 1: In the overall COSMOS cohort, cocoa flavanol supplementation will reduce risk of: (a)
injurious fall(s) resulting in a visit to a healthcare provider or hospital with medical record review and (b) two or
more falls per year and (c) injurious fall(s) (not resulting in healthcare utilization) as assessed by annual
questionnaires. Aim 2: In the clinic sub-cohort, cocoa flavanol supplementation will benefit physical
performance measures at 2-year post randomization, as assessed by grip strength, walking speed, and Short
Physical Performance Battery (a composite of standing balance, walking speed, and chair stands). Aim 3: In
the overall COSMOS cohort, cocoa flavanol supplementation reduces incident fractures as assessed by
annual questionnaires. We will explore whether effects of cocoa flavanols on fracture outcomes are mediated
through falls and/or bone density changes. In exploratory aims we will also assess effects of multivitamins on
these same outcomes. RCTs testing effects of multivitamins on falls and musculoskeletal outcomes are
lacking. This ancillary study maximizes cost-efficiency to fill gaps in knowledge regarding effects of flavanols
for the primary prevention of falls. We expect the proposed, rigorous translational study will elucidate whether
supplemental flavanols improve musculoskeletal health and prevent falls an...

## Key facts

- **NIH application ID:** 10793510
- **Project number:** 5R01AG071611-04
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** MERYL Susan LEBOFF
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $670,395
- **Award type:** 5
- **Project period:** 2021-05-15 → 2027-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10793510

## Citation

> US National Institutes of Health, RePORTER application 10793510, COcoa Supplement and Multivitamins Outcomes Study (COSMOS): Effects on Falls and Physical Performance (5R01AG071611-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10793510. Licensed CC0.

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