Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia (NCT04999488) | Clinical Trial Compass
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 range65 Years – 90 Years
SexALL
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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
✕. Inability and/or unwillingness to comply with the protocol as written
✕. Participant has had a significant cardiovascular event (e.g., myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening. In the event of a positive stress test, participants are referred to their primary care physician. If the electrocardiogram (ECG) is determined to be a false positive, participant may be allowed to participate in study after confirmatory records obtained.
✕. The presence of any condition which contraindicate moderate exercise and would result in the inability to comply with the protocol as written or would compromise participant safety or data integrity, will be considered on a case-by-case basis by the Principal investigator and the study physician.
What they're measuring
1
Measurement of skeletal muscle
Timeframe: Following 28 days of treatment
2
Measurement of platelet CoQ10 level
Timeframe: Following 28 days of treatment
Trial details
NCT IDNCT04999488
SponsorAdventHealth Translational Research Institute