NCT03325491|Terminated
Study Stopped
Challenges recruiting healthy, sedentary 65-75 year old males
Assessing the Effects of Increased Mitochondrial Function Exercise Training on Muscle Performance
Rejuvenate2
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Sponsor study identifier
interventional
2
1 country
1
Study Start
March 7, 2018
Actual (reported)Primary Completion
September 16, 2019
Actual (reported)Study Completion
September 16, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 16, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2017
Actual (reported)October 30, 2017
Actual (reported)March 7, 2018
Actual (reported)September 16, 2019
Actual (reported)September 16, 2019
Actual (reported)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
Chronic changes in habitual muscle protein synthetic rates
Baseline, 3 weeks and 6 weeks
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.
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: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
Alternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks.
NIHR Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW, United Kingdom
Colleen Deane, PhD
University of Exeter
2 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2017
First Posted
October 30, 2017
Study Start
March 7, 2018
Actual (reported)Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 16, 2019
Actual (reported)Study Completion
September 16, 2019
Actual (reported)Last Updated
September 27, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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