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Flavanols

Cocoa Extract + Multivitamins for Preventing Falls (COSMOS Trial)

N/A

Waitlist Available

Led By Meryl S LeBoff, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants in COSMOS (NCT02422745) who reported an injurious fall resulting in healthcare utilization (visit to a healthcare provider or hospital)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

COSMOS Trial Summary

This trial will study whether cocoa extract or multivitamins improve musculoskeletal health and prevent declining physical performance in older adults.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from cocoa extract could include digestive discomfort or allergic reactions. Multivitamins may cause mild upset stomach, headache, or unusual taste in the mouth.

COSMOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

COSMOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Injurious falls resulting in healthcare utilization (visit to a healthcare provider or hospital)

Recurrent falls (2 or more falls per year)

COSMOS Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Cocoa extract + multivitamin placeboActive Control2 Interventions

Group II: Cocoa extract placebo + multivitaminActive Control2 Interventions

Group III: Cocoa extract + multivitaminActive Control2 Interventions

Group IV: Cocoa extract placebo + multivitamin placeboPlacebo Group2 Interventions

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,448,435 Total Patients Enrolled

Meryl S LeBoff, MDPrincipal InvestigatorBrigham and Women's Hospital

Carolyn Crandall, MD, MSPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Cocoa extract (Flavanols) Clinical Trial Eligibility Overview. Trial Name: NCT05232669 — N/A

Broken Bones Research Study Groups: Cocoa extract + multivitamin placebo, Cocoa extract placebo + multivitamin, Cocoa extract placebo + multivitamin placebo, Cocoa extract + multivitamin

Broken Bones Clinical Trial 2023: Cocoa extract Highlights & Side Effects. Trial Name: NCT05232669 — N/A

Cocoa extract (Flavanols) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232669 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available in this research project?

"Clinicaltrials.gov states that while this medical trial was first posted on May 15th 2021 and last edited July 14th 2022, it is no longer looking for new participants. However, at present there are 389 other trials actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance

Meryl LeBoff 2021. "COcoa Supplement and Multivitamin Outcomes Study: Effects on Falls and Physical Performance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05232669.