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

NCT03325491 | Terminated

• 1 other identifier: 1617/024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Mitochondrial Function, Muscle Performance

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 weeks, 6 weeks

Secondary Outcomes (1)

• Chronic changes in habitual muscle protein synthetic rates

  Baseline, 3 weeks and 6 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Acipimox DIETARY_SUPPLEMENT

Acipimox plus exercise training: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.

Acipimox plus exercise training

Placebo DIETARY_SUPPLEMENT

Alternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks.

Placebo plus exercise training

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (1)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Interventions

acipimox

Study Officials

• Colleen Deane, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: October 30, 2017
• Study Start: March 7, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)