COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University of Birmingham

Brief Summary:
This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Nicotinamide Riboside Other: Placebo Phase 2

Detailed Description:

-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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nicotinamide Riboside
1000mg (2x250mg tablets twice daily)
Dietary Supplement: Nicotinamide Riboside
Placebo Comparator: Placebo
Two tablets twice daily
Other: Placebo

Primary Outcome Measures :
  1. 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

  2. Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics [ Time Frame: Following 3 weeks of NR supplementation ]

Secondary Outcome Measures :
  1. Improvement in response to oral glucose tolerance test/HOMA-IR [ Time Frame: Following 3 weeks of NR supplementation ]
  2. Improvement in lipid profile [ Time Frame: Following 3 weeks of NR supplementation ]
  3. Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production [ Time Frame: Following 3 weeks of NR supplementation ]
  4. Muscle biopsy: adaptive expression profile (genomic) [ Time Frame: Following 3 weeks of NR supplementation ]
  5. Changes in resting metabolic rate using indirect calorimetry [ Time Frame: Following 3 weeks of NR supplementation ]
  6. 24 hour urine collection - NAD+ metabolomics and changes in steroid ratios using Gas chromatography/ mass spectrometry [ Time Frame: Following 3 weeks of NR supplementation ]
  7. Muscle strength - grip testing [ Time Frame: Following 3 weeks of NR supplementation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   70 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male sex
  • Age 70-80 years
  • BMI 20-30kg/m2
  • Participants who are able to discontinue aspirin for 3 days prior to the muscle biopsy
  • Participants who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study

Exclusion Criteria:

  • Serious active medical conditions including inflammatory diseases or malignancies
  • Significant past medical history including diabetes mellitus, ischaemic heart disease, cerebrovascular disease, significant respiratory disease requiring medication, epilepsy
  • High blood pressure (BP>160/100mmHg)
  • Oral Anticoagulants (like Warfarin, Dabigatran, Rivaroxaban) or Clopidogrel therapy which will increase the risk of bruising following a muscle biopsy

Information from the National Library of Medicine

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 identifier (NCT number): NCT02950441

Layout table for location contacts
Contact: Yasir Elhassan, MRCP +441214158705
Contact: Gareth Lavery, PhD +441214143917

Layout table for location information
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Yasir Elhassan, MRCP    +441214158705   
Sponsors and Collaborators
University of Birmingham
Layout table for investigator information
Principal Investigator: Gareth Lavery, PhD Institute of Metabolism and Systems Research, University of Birmingham

Layout table for additonal information
Responsible Party: University of Birmingham Identifier: NCT02950441    
Other Study ID Numbers: RG_15-152
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Birmingham:
Nicotinamide Riboside
Nicotinamide Adenine Dinucleotide
Skeletal muscle
Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotinic Acids
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents