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

Impaired Mitochondrial Function, Muscle Performance Clinical Trial

— Rejuvenate2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03325491
• Other study ID #: 1617/024
• Status: Terminated
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: September 2019
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Impaired Mitochondrial Function, Muscle Performance

Intervention

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

Locations

Country	Name	City	State
United Kingdom	NIHR Exeter Clinical Research Facility	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline, 3 weeks and 6 weeks