Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)
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|ClinicalTrials.gov Identifier: NCT02950441|
Recruitment Status : Unknown
Verified October 2016 by University of Birmingham.
Recruitment status was: Recruiting
First Posted : November 1, 2016
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aging||Dietary Supplement: Nicotinamide Riboside Other: Placebo||Phase 2|
-NAD+ sensitive metabolic decline in ageing, including sarcopenia, leads to a reduction in energy metabolism, contribute to chronic inflammation, disposing individuals to metabolic disease and overall decreased later-life health. Prominent metabolic changes include a decline in NAD+ content and deterioration in muscle NAD+ mediated signalling and mitochondrial function, ultimately compromising skeletal muscle and whole body energy homeostasis.
The most efficient means to boost NAD+ in muscle appears to be oral delivery of NR, and participants will be supplemented with 1000mg NR (2x x250mg tablets twice daily) for 3 weeks.
- Hypothesis: elevating skeletal muscle NAD+ bioavailability using NR supplementation will increase markers of mitochondrial function and that will manifest as a more favourable metabolic profile.
- Study Setting: the study will be carried out at the NIHR/Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
Experimental: Nicotinamide Riboside
1000mg (2x250mg tablets twice daily)
Dietary Supplement: Nicotinamide Riboside
Placebo Comparator: Placebo
Two tablets twice daily
- Mitochondrial function assessment in skeletal muscle using high resolution respirometry [ Time Frame: Following 3 weeks of NR supplementation ]Mitochondrial function assessment on muscle biopsies using high resolution respirometry
- Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics [ Time Frame: Following 3 weeks of NR supplementation ]
- Improvement in response to oral glucose tolerance test/HOMA-IR [ Time Frame: Following 3 weeks of NR supplementation ]
- Improvement in lipid profile [ Time Frame: Following 3 weeks of NR supplementation ]
- Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production [ Time Frame: Following 3 weeks of NR supplementation ]
- Muscle biopsy: adaptive expression profile (genomic) [ Time Frame: Following 3 weeks of NR supplementation ]
- Changes in resting metabolic rate using indirect calorimetry [ Time Frame: Following 3 weeks of NR supplementation ]
- 24 hour urine collection - NAD+ metabolomics and changes in steroid ratios using Gas chromatography/ mass spectrometry [ Time Frame: Following 3 weeks of NR supplementation ]
- Muscle strength - grip testing [ Time Frame: Following 3 weeks of NR supplementation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950441
|Contact: Yasir Elhassan, MRCPemail@example.com|
|Contact: Gareth Lavery, PhDfirstname.lastname@example.org|
|University Hospitals Birmingham NHS Foundation Trust||Recruiting|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Contact: Yasir Elhassan, MRCP +441214158705 email@example.com|
|Principal Investigator:||Gareth Lavery, PhD||Institute of Metabolism and Systems Research, University of Birmingham|