Increasing Mitochondrial Function on Skeletal Muscle Performance in Older Men

NCT02792621 | Completed

• 1 other identifier: R&D no 1608287
• Study Type: interventional
• Target: 16
• 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, by measuring how the muscles work and respond to exercise before and after taking the supplement. 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, day 7 and day 14) and analysed for content and subsequently for oxidative respiratory function using the Seahorse technique, and maximal rates of Adenosine Triphosphate (ATP) production.

  Baseline, day 7, day 14

Secondary Outcomes (1)

• Chronic changes in habitual muscle protein synthetic rates

  Baseline and then daily for 14 days

Study Arms (2)

active oral supplement

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 a 14 day period.

Dietary Supplement: Acipimox

placebo supplement

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

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

active oral supplement

placebo DIETARY_SUPPLEMENT

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.

placebo supplement

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

Sponsors & Collaborators

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

Study Sites (1)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Interventions

acipimox

Study Officials

• Timothy Etheridge, PhD

  University of Exeter

  STUDY DIRECTOR

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: May 24, 2016
• First Posted: June 7, 2016
• Study Start: November 8, 2016
• Primary Completion: June 26, 2018
• Study Completion: December 15, 2019
• Last Updated: March 10, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)