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

Trial Summary

What is the purpose of this trial?

This trial is testing if taking CoQ10 pills can help older adults with muscle loss. The study lasts for about a month. Researchers want to see if CoQ10 improves muscle strength, aerobic capacity, and overall physical function by helping cells make more energy. Coenzyme Q10 (CoQ10) has been studied for its potential benefits in improving muscle metabolism, exercise performance, and reducing fatigue.

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.

What data supports the effectiveness of the drug BPM31510, which includes Coenzyme Q10?

Research shows that Coenzyme Q10, a component of BPM31510, has improved bioavailability (how well a drug is absorbed in the body) when delivered through certain formulations, like self-emulsifying systems and lipid microspheres, suggesting it could be more effective in these forms. ^{1 2 3 4 5}

Is the treatment BPM31510 (ubidecarenone) generally safe for humans?

Research indicates that ubidecarenone (Coenzyme Q10), a component of BPM31510, has been consumed by humans for centuries without notable adverse effects. Studies show it does not cause genetic mutations or chromosomal damage in various tests, suggesting it is generally safe. ^{1 3 6 7 8}

How is the drug BPM31510 different from other treatments?

BPM31510, also known as Coenzyme Q10, is unique because it can be administered as an injectable nanosuspension, which may enhance its absorption and effectiveness compared to traditional oral formulations. This method of delivery could potentially improve the bioavailability (how well the body can use the drug) of CoQ10, making it more effective for patients. ^{1 2 3 5 9}

Research Team

Paul Coen, PhD

Principal Investigator

AdventHealth Translational Research Institute

Eligibility Criteria

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

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

Treatment Details

Interventions

• BPM31510

Participant Groups

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+

Findings from Research

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, 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Formulation and evaluation of ubidecarenone transdermal delivery systems. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

Analysis of ubidecarenone (CoQ10) aqueous samples using reversed phase liquid chromatography. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Enhanced oral bioavailability of Coenzyme Q10 by self-emulsifying drug delivery systems. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Comparison of bioavailability of two ubidecarenone products in healthy Korean volunteers. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Intestinal absorption enhancement of coenzyme Q10 with a lipid microsphere. [2014]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of the mutagenic potential of ubidecarenone using three short-term assays. [2014]

8. Japan pubmed.ncbi.nlm.nih.gov

Genotoxicity studies of ubidecarenone (coenzyme Q10) manufactured by bacteria fermentation. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Interaction of ubiquinone-10 with dipalmitoylphosphatidylcholine and their formation of small dispersed particles. [2019]