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

Overview

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.

Full Title of Study: “Assessing the Effects of Increased Mitochondrial Function and Chronic Aerobic or Resistance Exercise Training on Skeletal Muscle Performance in Older Men; a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 16, 2019

Interventions

  • Dietary Supplement: Acipimox
    • Acipimox plus exercise training: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
  • Dietary Supplement: Placebo
    • Alternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks.

Arms, Groups and Cohorts

  • Experimental: Acipimox plus exercise training
    • 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.
  • Placebo Comparator: Placebo plus exercise training
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Chronic changes in habitual muscle protein synthetic rates
    • Time Frame: 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

Participating in This Clinical Trial

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 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

Gender Eligibility: Male

Minimum Age: 65 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Exeter
  • Collaborator
    • Royal Devon and Exeter NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Colleen Deane, PhD, Principal Investigator, University of Exeter

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