WithdrawnEarly Phase 1

Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia

Stopped: Drug manufacturing update. Study site will proceed with study in future.

United States0Started 2023-12

Plain-language summary

This study is being done to gather data on whether oral supplementation of CoQ10 is enriched in the blood and muscles in older adults with sarcopenia. This study involves 28 consecutive days of oral CoQ10 supplementation to explore changes in muscle strength, aerobic capacity and physical function with CoQ10 supplementation.

Who can participate

Age range

65 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be male or female, ages 65 through 90 years of age.
. Participant must be sedentary, defined as ≤ 1 structured intentional continuous exercise session (approximately 30 mins) per week.
. Participant must be sarcopenic, defined as having a skeletal muscle mass index (SMI) of \<7.25 kg/m2 for males or \<5.67 kg/m2 for females via DEXA scan.
. Participant states willingness to follow the protocol as described and will complete any forms needed throughout the study.
. Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of skeletal muscle

Timeframe: Following 28 days of treatment

Measurement of platelet CoQ10 level

Timeframe: Following 28 days of treatment

Trial details

NCT IDNCT04999488

SponsorAdventHealth Translational Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Sarcopenia trials