Impaired Mitochondrial Function, Muscle PerformanceRejuvenate2NCT03325491
Assessing the Effects of Increased Mitochondrial Function Exercise Training on Muscle Performance
A study testing Acipimox in people with Impaired Mitochondrial Function, Muscle Performance, run by University of Exeter at 1 site in United Kingdom.
Trial summary
As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. Read more about this study
- Who is it for?
- Ages 65 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Mitochondrial Function, Muscle Performance
- What is being tested?
- Acipimox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Mar 2018to 16 Sep 2019
- Phase
- Interventional
- 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 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- Age between 65-75 years
- Body mass index between 19-29
- No active cardiovascular or metabolic disease
- No active respiratory disease
- No current musculoskeletal injuries
- A sedentary lifestyle (i.e. does not engage in strenuous, planned physical activity)
- The ability to give informed consent
Who cannot join
- Currently taking a statin drug or NSAIDs
- Have a current peptic ulcer
- Have any renal impairment
- Have a known hypersensitivity to Acipimox
- Suffer from vertigo
- Smoker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW
About this study
Official title: Assessing the Effects of Increased Mitochondrial Function and Chronic Aerobic or Resistance Exercise Training on Skeletal Muscle Performance in Older Men; a Pilot Study
As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail. This is possible by measuring how the muscles work and respond to exercise before and after taking the supplement alongside an aerobic (i.e. cycling) and resistance (i.e. weight lifting) exercise programme. This will give us the basic information investigators would need to see if this is a useful idea.
- Being tested
- Acipimox, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcipimoxDietary supplement
Acipimox plus exercise training: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
PlaceboDietary supplement
Alternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acipimox plus exercise training | Experimental | The active supplement will contain the prescription drug Acipimox (250 mgs) , a nicotinic acid precursor traditionally used to lower blood lipid levels. The supplement will be administered 3 times per day, for 6 weeks. Receives: Dietary Supplement: Acipimox |
| Placebo plus exercise training | Placebo comparator | The placebo supplement will contain only cellulose microcrystalline. This is an inert substance widely used in many pill and tablet formulations. It is an insoluble fibre and is not absorbed into the blood stream therefore is unlikely to cause toxicity when taken orally. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitochondrial function
Mitochondria will be extracted from muscle samples immediately post-biopsy (biopsies taken baseline, week 3 and week 6) and analysed for content and subsequently for oxidative respiratory function using the Oroboros technique, and maximal rates of Adenosine Triphosphate (ATP) production.
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (1)
Chronic changes in habitual muscle protein synthetic rates
Baseline saliva samples then frequent saliva samples over 6 weeks following oral ingestion of the stable isotope deuterium oxide (D2O, or 'heavy water') will be analysed by gas-chromatography-pyrolysis-isotope ratio mass-spectrometry. analysis. Muscle samples collected at baseline, 3 weeks, 6 weeks will also be analysed by gas-chromatography-pyrolysis-isotope ratio mass-spectrometry
Measured: Baseline, 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start7 Mar 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Why it stopped: Challenges recruiting healthy, sedentary 65-75 year old males
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Mitochondrial Function, Muscle PerformanceStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Colleen Deane, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325491
- Sponsor's protocol ID
- 1617/024
- Acronym
- Rejuvenate2
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Increased Mitochondrial Function and Chronic Aerobic or Resistance Exercise Training on Skeletal Muscle Performance in Older Men; a Pilot Study
- ClinicalTrials.gov ID
- NCT03325491
- Acronym / sponsor ID
- Rejuvenate2 / 1617/024
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges recruiting healthy, sedentary 65-75 year old males
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 30 Oct 2017 (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.
As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail. This is possible by measuring how the muscles work and respond to exercise before and after taking the supplement alongside an aerobic (i.e. cycling) and resistance (i.e. weight lifting) exercise programme. This will give us the basic information investigators would need to see if this is a useful idea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acipimox plus exercise training | Experimental | Dietary Supplement: AcipimoxThe active supplement will contain the prescription drug Acipimox (250 mgs) , a nicotinic acid precursor traditionally used to lower blood lipid levels. The supplement will be administered 3 times per day, for 6 weeks. |
| Placebo plus exercise training | Placebo comparator | Dietary Supplement: PlaceboThe placebo supplement will contain only cellulose microcrystalline. This is an inert substance widely used in many pill and tablet formulations. It is an insoluble fibre and is not absorbed into the blood stream therefore is unlikely to cause toxicity when taken orally. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Male
- Age between 65-75 years
- Body mass index between 19-29
- No active cardiovascular or metabolic disease
- No active respiratory disease
Key exclusion criteria (6 listed)
- Currently taking a statin drug or NSAIDs
- Have a current peptic ulcer
- Have any renal impairment
- Have a known hypersensitivity to Acipimox
- Suffer from vertigo
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 |
|---|---|---|
| AcipimoxAcipimox plus exercise training: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form. | Dietary supplement | Acipimox plus exercise training |
| PlaceboAlternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks. | Dietary supplement | Placebo plus exercise training |
Primary outcome
Change in mitochondrial function
Time frame: Baseline, 3 weeks, 6 weeks
Mitochondria will be extracted from muscle samples immediately post-biopsy (biopsies taken baseline, week 3 and week 6) and analysed for content and subsequently for oxidative respiratory function using the Oroboros technique, and maximal rates of Adenosine Triphosphate (ATP) production.
1 secondary outcome
Chronic changes in habitual muscle protein synthetic rates
Time frame: Baseline, 3 weeks and 6 weeks
Results and safety
The study was stopped early (reason given: Challenges recruiting healthy, sedentary 65-75 year old males). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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.
Colleen Deane, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acipimox in people with Impaired Mitochondrial Function, Muscle Performance, run by University of Exeter at 1 site in United Kingdom.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Sep 2019. 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 Kingdom. 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.
Are results available for this study?
The study was stopped early (reason given: Challenges recruiting healthy, sedentary 65-75 year old males). Results are not available in the source record.
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?
Change in mitochondrial function (time frame: Baseline, 3 weeks, 6 weeks). 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 27 Sep 2019.