Cocoa Extract + Multivitamins for Preventing Falls
(COSMOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cocoa extract or multivitamins can improve muscle and bone health and prevent falls in older adults. Researchers aim to determine if these supplements can also reduce the risk of heart disease and cancer. Participants will receive either cocoa extract and a placebo multivitamin, a multivitamin and a placebo cocoa extract, both placebos, or both active supplements. The trial seeks participants who have experienced a fall requiring medical attention or who fall at least twice a year.
As an unphased trial, this study offers a unique opportunity to contribute to understanding how these supplements might enhance overall health and prevent falls in older adults.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both cocoa extract and multivitamins are generally safe for use. Studies have found that cocoa extract is well-tolerated and may offer health benefits, such as reducing deaths from heart-related issues by 27%. Specifically, fewer people died from heart problems when using cocoa extract. Multivitamins are widely used and usually considered safe, supporting overall health and potentially lowering the risk of some heart-related events.
While these supplements have shown benefits, no serious side effects have been reported in these studies. This suggests that both cocoa extract and multivitamins are safe for most people. However, since individual responses vary, consulting a healthcare provider before starting any new supplement is always advisable.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for preventing falls because they use cocoa extract and multivitamins, which are not typical components of current fall prevention strategies. Unlike the standard care options that often involve physical therapy or medication to improve bone density and balance, cocoa extract is derived from the cacao bean and is rich in antioxidants, which may support brain and muscle function. Multivitamins provide a broad spectrum of essential nutrients, potentially addressing multiple deficiencies that could contribute to falls. This combination of cocoa extract and multivitamins offers a novel approach by focusing on nutritional supplementation, which could be a simple and accessible preventive measure.
What evidence suggests that this trial's treatments could be effective for preventing falls?
This trial will compare the effects of cocoa extract and multivitamins on preventing falls. Research has shown that cocoa extract might reduce the risk of dying from heart disease by 27% in older adults. However, it does not significantly lower the risk of heart-related problems or bone fractures. Studies suggest that multivitamins could reduce the risk of major heart issues, but strong evidence is lacking for their ability to significantly prevent falls or improve bone and muscle health. Researchers are exploring the benefits of using both together, but current findings are mixed regarding their effectiveness for these specific health concerns. Participants in this trial will receive either cocoa extract with a multivitamin placebo, a multivitamin with a cocoa extract placebo, both active treatments, or both placebos.34567
Who Is on the Research Team?
Carolyn Crandall, MD, MS
Principal Investigator
University of California, Los Angeles
Meryl S LeBoff, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cocoa extract supplement or multivitamin supplement to assess effects on musculoskeletal health and prevention of falls
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cocoa extract
- Multivitamin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor