Cocoa Extract + Multivitamins for Preventing Falls

(COSMOS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Under 60, Not in COSMOS

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

21442 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cocoa extract + Multivitamins for preventing falls?

Research shows that vitamin D, a common component in multivitamins, can help reduce the risk of falls, especially in older adults and postmenopausal women. This suggests that multivitamins containing vitamin D might contribute to fall prevention. ^{1 2 3 4 5}

Is the combination of cocoa extract and multivitamins safe for humans?

Research suggests that multivitamins are generally safe when consumed at levels defined by dietary guidelines, but safety can vary based on the specific combination and amounts of nutrients. It's important to consider individual differences in how people consume fortified foods and supplements to ensure safety. ^{6 7 8 9 10}

How does the treatment of cocoa extract and multivitamins prevent falls differently from other treatments?

This treatment is unique because it combines cocoa extract, known for its antioxidant properties, with multivitamins, which may support overall health. While traditionally used for cardiovascular and cancer prevention, this combination is being explored for its potential to prevent falls, a novel application compared to standard treatments. ^{11 12 13 14 15}

Research Team

Meryl S LeBoff, MD

Principal Investigator

Brigham and Women's Hospital

Carolyn Crandall, MD, MS

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for older adults in the U.S. who are part of an ongoing study (COSMOS). It's specifically for men aged 60+ and women aged 65+ who have had falls causing them to seek healthcare or those with a history of frequent falls.

Inclusion Criteria

Participants in COSMOS (NCT02422745) who reported recurrent falls (2 or more falls per year)

I was in the COSMOS study and had a fall that needed medical care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cocoa extract supplement or multivitamin supplement to assess effects on musculoskeletal health and prevention of falls

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Cocoa extract
• Multivitamin

Trial Overview The trial is testing whether cocoa extract supplements, rich in flavanols, or standard multivitamins can improve musculoskeletal health and prevent falls and declining physical performance in older adults.

Participant Groups

Group I: Cocoa extract + multivitamin placebo Active Control 2 Interventions

Group II: Cocoa extract placebo + multivitamin Active Control 2 Interventions

Group III: Cocoa extract + multivitamin Active Control 2 Interventions

Group IV: Cocoa extract placebo + multivitamin placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

In a study involving 1118 patients across 10 community pharmacies, it was found that 58.8% of patients were using both prescription drugs and natural health products (NHPs) concurrently, which significantly increased their risk of experiencing adverse events (AEs).

Patients using both prescription drugs and NHPs were 6.4 times more likely to report an AE compared to those using only prescription drugs, highlighting the importance of monitoring concurrent use for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. Necyk, C., Tsuyuki, RT., Boon, H., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of vitamin D supplementation on types of falls. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Association of vitamin and/or nutritional supplements with fall among patients with diabetes: A prospective study based on ACCORD and UK Biobank. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Low-dose vitamin D prevents muscular atrophy and reduces falls and hip fractures in women after stroke: a randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fall prevention with supplemental and active forms of vitamin D: a meta-analysis of randomised controlled trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of isolated vitamin D supplementation on the rate of falls and postural balance in postmenopausal women fallers: a randomized, double-blind, placebo-controlled trial. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of different maximum safe levels in fortified foods and supplements using a probabilistic risk assessment approach. [2010]

7. England pubmed.ncbi.nlm.nih.gov

Systematic review of safety and tolerability of a complex micronutrient formula used in mental health. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dietary supplements and disease prevention - a global overview. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of food fortification with calcium among adults in Finland. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Design and baseline characteristics of participants in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Plasma LDL and HDL cholesterol and oxidized LDL concentrations are altered in normo- and hypercholesterolemic humans after intake of different levels of cocoa powder. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

How Healthy Is It to Fortify Cocoa-Based Products with Cocoa Flavanols? A Comprehensive Review. [2023]

14. England pubmed.ncbi.nlm.nih.gov

In-vitro effects of polyphenols from cocoa and beta-sitosterol on the growth of human prostate cancer and normal cells. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Regular consumption of a cocoa product improves the cardiometabolic profile in healthy and moderately hypercholesterolaemic adults. [2017]