NADMet
Research type
Research Study
Full title
Nicotinamide Adenine Dinucleotide and Skeletal Muscle Phenotype
IRAS ID
183388
Contact name
Gareth Lavery
Contact email
Sponsor organisation
University of Birmingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, months, days
Research summary
Title\nNicotinamide Adenine Dinucleotide and Skeletal Muscle Phenotype (NADMet)\n\nDesign\nThis is a single centre, double blind, randomised, placebo-controlled crossover study to assess the physiological effects of the administration of Niagen (ChromaDex Inc, USA) to healthy elderly male volunteers.\n\nObjectives\nStudy is designed to assess the physiological consequences of elevating Nicotianmide Adenine Dinulcoetide (NAD) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype. \n\nSample Size\n12 healthy elderly male volunteers.\n \nOutcomes\nPrimary: \nMitochondrial function assessment in the skeletal muscle\nSkeletal muscle NAD levels increase in vastus lateralis biopsy.\n\nSecondary:\nImprovement in response to oral glucose tolerance test and in HOMA-IR.\nImprovement in lipid profile.\nMuscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption, CO2 production\nMuscle biopsy: adaptive expression prolife (genomic)\n\n\nOther:\nIndirect calorimetry measurements.\n24 hour urine collection - NAD, NAD metabolomes and changes in steroid ratios using Gas chromatography/ mass spectrometry. \nMuscle strength - grip testing\nUnbiased approaches including genetic testing, transcriptomics, epigenetics, proteomics and metabolomics will be used to maximise data return. \n\nKey Eligibility Criteria\n\nInclusion criteria\nMale sex\nAge 70-80 years\nBMI 20-30kg/m2\nPatients who are able to discontinue aspirin for 3 days prior to the muscle biopsy. \nPatients who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study \n\nExclusion criteria\n\nSerious active medical conditions including inflammatory diseases or malignancies. \nSignificant past medical history including diabetes mellitus, ischaemic heart disease, cerebrovascular disease, significant respiratory disease requiring medication, epilepsy. \nHigh blood pressure (BP>160/100mmHg)\nOral Anticoagulants (like Warfarin, Dabigatran, Rivaroxaban) or Clopidogrel therapy which will increase the risk of bruising following a muscle biopsy\n\n\nVolunteers will be randomised to receive 21 days treatment with either;\n\n1-\tPlacebo- 2 tablets twice daily\n2-\t1000mg NR-2 x 250mg tablets twice daily.\n\nFollowing a minimum of 3 weeks washout period volunteers will cross-over to the other treatment arm respectively. \n\nThe study will be carried out at the NIHR/Wellcome Trust Clinical Research Facility at Queen Elizabeth Hospital Birmingham.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0159
Date of REC Opinion
11 May 2016
REC opinion
Further Information Favourable Opinion