SarcopeniaEarly Phase 1COQ10NCT04999488
Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older Adults With Sarcopenia
A Early Phase 1 study testing BPM31510 in people with Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- BPM31510
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participant is actively pursuing weight loss and/or lifestyle changes.
- History of gastrointestinal or intracranial hemorrhage.
- History of stroke or cerebrovascular accident.
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- Participant has diabetes.
- Weight stable -no gain/loss by self-report of ≥ 10 lbs in 6 months prior to screening
- BMI 40.0 kg/m2
- Untreated or poorly controlled hypertension (SBP 150, DBP 95), or hypotension (SBP 100 DBP 60)
- Participant has untreated hyperthyroidism (TSH (0.5mIU/L) or untreated hypothyroidism (TSH 10mIU/L).
- Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
- Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations, e.g., Aleve, Motrin, ibuprofen, naproxen, low dose aspirin).
- Participant has had surgery requiring > 2 days of hospitalization in the last 1 month prior to screening visit.
- Participant has an active malignancy or autoimmune disease.
- Participant has current significantly impaired liver function in the opinion of the study Medical Investigator (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥ 2.5 times normal limit.
- Participant has a chronic, contagious, or infectious diseases, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
- Participant currently has uncontrolled severe diarrhea, nausea or vomiting.
- Participant has an obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as stage III or above gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis and bariatric surgery.
- Participant has a mini-Mental State Examination score < 21.
- Unable to participate in DXA assessments due to physical limitations of equipment tolerances (e.g., DXA 450-pound weight limit), claustrophobia, or based on Investigator's judgment at screening.
- Participant has a sensitivity or allergy to lidocaine.
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
- Participant has peripheral vascular disease.
- Participant has proteinuria defined as > 1+; approximately 30 mg/dl.
- Clinically significant abnormality on ECG
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
Official title: Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older
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.
- Conditions
- Sarcopenia
- Being tested
- BPM31510, Placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPM31510Drug
A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.
PlaceboOther
A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with sarcopenia (placebo) | Placebo comparator | Not described Receives: Other: Placebo |
| Older adults with sarcopenia (drug) | Active comparator | Not described Receives: Drug: BPM31510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of skeletal muscle
We will evaluate changes in mitochondrial function (respiration) on permeabilized skeletal muscle fiber bundles obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.
Measured: Following 28 days of treatment
Measurement of platelet CoQ10 level
We will evaluate changes in mitochondrial function (respiration) on cells (platelets) obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.
Measured: Following 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Drug manufacturing update. Study site will proceed with study in future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Coen, PhD, Principal investigator, AdventHealth Translational Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999488
- Sponsor's protocol ID
- 1665113
- Acronym
- COQ10
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Orally Administered BPM31510 on Mitochondrial Energetics in Older
- ClinicalTrials.gov ID
- NCT04999488
- Acronym / sponsor ID
- COQ10 / 1665113
- Conditions
- Sarcopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug manufacturing update. Study site will proceed with study in future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel arm trial in which the supplementation with oral BPM 31510 or placebo will be blind.
| Arm | Type | Receives |
|---|---|---|
| Older adults with sarcopenia (placebo) | Placebo comparator | Other: Placebo |
| Older adults with sarcopenia (drug) | Active comparator | Drug: BPM31510 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
- Participant is actively pursuing weight loss and/or lifestyle changes.
- History of gastrointestinal or intracranial hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPM31510A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime. | Drug | Older adults with sarcopenia (drug) |
| PlaceboA total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime. | Other | Older adults with sarcopenia (placebo) |
Primary outcome
Measurement of skeletal muscle
Time frame: Following 28 days of treatment
We will evaluate changes in mitochondrial function (respiration) on permeabilized skeletal muscle fiber bundles obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.
Measurement of platelet CoQ10 level
Time frame: Following 28 days of treatment
We will evaluate changes in mitochondrial function (respiration) on cells (platelets) obtained from biopsies of the vastus lateralis and blood draws, respectively. Blood and muscle biospecimens will also be obtained for multi-omics analysis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Coen, PhD principal investigator
AdventHealth Translational Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BPM31510 in people with Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of skeletal muscle (time frame: Following 28 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.