An interventional study of Acipimox and placebo in Impaired Mitochondrial Function, Muscle Performance, sponsored by Royal Devon and Exeter NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to male participants aged 65 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Not applicable, Interventional, and Prevention
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.
A defining feature of ageing is loss of muscle mass ('sarcopenia') and associated functional weakness ('dynapenia'). A common characteristic of dynapenia is lowered mitochondrial content and metabolic function, causing reduced aerobic capacity, increased sensations of effort and impaired lipid oxidation (with resultant glucose intolerance). Exercise training improves mitochondrial and muscle function in ageing populations, however such adaptations remain below that of young counterparts, suggesting alternative approaches are required. Pre-clinical studies show that dietary supplementation with precursors of nicotinamide adenine dinucleotide (NAD+) restore mitochondrial biogenesis and oxidative capacity in ageing rodents and diabetic humans. However, whether NAD+ precursors rejuvenate mitochondrial capacity and, ultimately, muscle function in older humans is unknown. This pilot project will therefore investigate the efficacy of NAD+ precursor supplementation for increasing muscle performance in normally active older men, combined with examination of the molecular and metabolic mechanisms regulating physiological responses.
Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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
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
Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
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.
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.
Time frame: Baseline, day 7, day 14
Chronic changes in habitual muscle protein synthetic rates
baseline saliva samples then daily saliva samples 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.
Time frame: Baseline and then daily for 14 days
Plan to share: No
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Royal Devon and Exeter NHS Foundation Trust