CoQ10 for Sarcopenia

(COQ10 Trial)

Overseen By Recruitment Dept

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Anti-inflammatories, Corticosteroids

Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, Infection, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement called CoQ10 (also known as BPM31510) can improve muscle strength and physical function in older adults with sarcopenia, a condition characterized by weakened muscles. Participants will take the supplement for 28 days, and researchers will assess its effects on muscle strength and overall energy levels. The study includes two groups: one will receive the CoQ10 supplement, while the other will receive a placebo (a pill with no active ingredients). Individuals who have been inactive (less than one exercise session per week) and have weak muscles may be suitable for this trial. As an Early Phase 1 trial, this study aims to understand how CoQ10 works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-inflammatory medications or have taken them within a week before the screening.

Is there any evidence suggesting that BPM31510 is likely to be safe for humans?

Research shows that BPM31510, an oral form of CoQ10, has been tested in healthy individuals. The results indicated that it was safe and well-tolerated. CoQ10, a natural compound in the body, is often used as a supplement for various health benefits.

In another study, CoQ10 was linked to better heart health, as higher blood levels were associated with a lower risk of heart issues. These findings suggest that CoQ10 is not only safe but may also offer additional health benefits.

Overall, previous studies indicate that BPM31510 is well-tolerated. While every treatment can have side effects, current evidence supports its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sarcopenia?

Researchers are excited about BPM31510 because it targets mitochondrial energetics, which is a unique approach for treating sarcopenia. Unlike standard treatments that often focus on exercise and nutritional supplements to improve muscle mass and function, BPM31510 works at the cellular level to enhance energy production within the muscles. This innovative mechanism could potentially lead to more effective and faster improvements in muscle strength and function for older adults suffering from sarcopenia.

What evidence suggests that CoQ10 supplementation might be effective for sarcopenia?

Research has shown that CoQ10 supplements might help with muscle loss, a common issue in older adults. Some studies found that CoQ10 pills can increase muscle strength and improve physical performance. For instance, participants taking CoQ10 reported more energy than those on a placebo. CoQ10 appears to enhance mitochondrial function, which boosts energy production in cells. While more research is needed, these early findings suggest CoQ10 could help those experiencing muscle loss. In this trial, participants will receive either BPM31510, a CoQ10 injectable nanosuspension, or a placebo to evaluate its effectiveness in treating sarcopenia. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Coen, PhD

Principal Investigator

AdventHealth Translational Research Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Participant has diabetes.

Weight stable -no gain/loss by self-report of ≥ 10 lbs in 6 months prior to screening

You are currently working on losing weight or making lifestyle changes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral CoQ10 supplementation for 28 consecutive days to explore changes in muscle strength, aerobic capacity, and physical function

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BPM31510

How Is the Trial Designed?

Group I: Older adults with sarcopenia (drug) Active Control 1 Intervention

Group II: Older adults with sarcopenia (placebo) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

Published Research Related to This Trial

Ubidecarenone, delivered through BPM31510, shows a significant therapeutic potential against glioblastoma, as it selectively targets cancer cells with elevated oxidative stress, leading to increased sensitivity compared to non-cancer cells.

In vivo studies demonstrated that treatment with ubidecarenone resulted in over 25% long-term survival in a rodent glioma model, indicating its effectiveness in enhancing survival in aggressive cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High levels of ubidecarenone (oxidized CoQ10) delivered using a drug-lipid conjugate nanodispersion (BPM31510) differentially affect redox status and growth in malignant glioma versus non-tumor cells. Sun, J., Patel, CB., Jang, T., et al.[2021]

The study demonstrated that transdermal delivery systems (TDS) for Coenzyme Q10 (CoQ10) can be effectively developed, with formulations containing 6% linoleic or oleic acid showing the highest permeation rates.

In vivo pharmacokinetic results indicated that TDS with oleic acid provided a favorable absorption profile, with lower peak concentration and prolonged effects compared to oral administration, suggesting a potentially safer and more effective delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulation and evaluation of ubidecarenone transdermal delivery systems. Jung, SY., Kang, EY., Choi, YJ., et al.[2014]

Ubidecarenone (CoQ(10)) has been shown to be safe in toxicological studies, with no evidence of mutagenic potential at high doses, including up to 2000 mg/kg/day in mice.

The studies demonstrated that ubidecarenone did not cause chromosomal aberrations or reverse mutations in various tests, indicating its safety for human consumption, especially given its long history of use in foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the mutagenic potential of ubidecarenone using three short-term assays. Kitano, M., Hosoe, K., Fukutomi, N., et al.[2014]

Ubidecarenone, a form of coenzyme Q10 used in heart failure therapy, was found to have no genotoxic effects when produced through bacteria fermentation, based on rigorous testing methods including the Ames test and chromosome aberration test.

The study confirms the safety profile of ubidecarenone manufactured by bacteria fermentation, indicating it does not cause genetic mutations or chromosomal damage, which is important for its use as a dietary supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genotoxicity studies of ubidecarenone (coenzyme Q10) manufactured by bacteria fermentation. Yamaguchi, N., Nakamura, K., Oguma, Y., et al.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-sarcopenia-9-2021-da24d

Impact of Orally Administered BPM31510 on Mitochondrial ... This trial is testing if taking CoQ10 pills can help older adults with muscle loss. The study lasts for about a month.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37498106/

Effect of Coenzyme Q10 Supplementation on Sarcopenia, ... This scoping review identified and summarized 4 studies that assessed the effects of exogenous CoQ10 on outcomes relating to sarcopenia, frailty, and falls.

3. bpgbio.com bpgbio.com/clinical-trials/sarcopenia/

Sarcopenia What is the trial status of BPGbio's BPM 31510 for Sacropenia? BPGbio is initiating a Phase II clinical trial using oral BPM31510, a CoQ10 nanosuspension ...

4. mdpi.com mdpi.com/2077-0383/13/13/3741

Effect of Coenzyme Q 10 on Physical Performance in Older ... Results: After the first 4 weeks of dietary supplementation, individuals taking CoQ10 phytosome showed a greater improvement in asthenia compared to the placebo ...

5. ctv.veeva.com ctv.veeva.com/study/impact-of-orally-administered-bpm31510-on-mitochondrial-energetics-in-older-adults-with-sarcopenia

Impact of Orally Administered BPM31510 on Mitochondrial ... This study involves 28 consecutive days of oral CoQ10 supplementation to explore changes in muscle strength, aerobic capacity and physical ...

6. mdpi.com mdpi.com/2076-3921/11/2/279

Levels of Plasma Coenzyme Q10 Are Associated with ... Our results indicate that high CoQ10 levels are directly associated with lower cardiovascular risk measured by the quotient total cholesterol/HDL cholesterol.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02664376

https://clinicaltrials.gov/ct2/show/NCT02664376 No information is available for this page.