Assessing the Effects of Increased Mitochondrial Function Exercise Training on Muscle Performance

Not Applicable

Terminated

• Conditions: Impaired Mitochondrial Function, Muscle Performance
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Acipimox

• Registration Number: NCT03325491
• Lead Sponsor: University of Exeter

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-30
• Study Start: 2018-03-07
• Status Verified: 2019-09
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus exercise training	Placebo	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.
Acipimox plus exercise training	Acipimox	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.

Primary Outcome Measures

Name	Time	Method
Change in mitochondrial function	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.

Secondary Outcome Measures

Name	Time	Method
Chronic changes in habitual muscle protein synthetic rates	Baseline, 3 weeks and 6 weeks	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

Trial Locations

Locations (1)

NIHR Exeter Clinical Research Facility; 🇬🇧 Exeter, Devon, United Kingdom