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Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)

This study is currently recruiting participants.
Verified October 2016 by University of Birmingham
Sponsor:
ClinicalTrials.gov Identifier:
NCT02950441
First Posted: November 1, 2016
Last Update Posted: June 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Birmingham
  Purpose
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 Intervention Phase
Aging Dietary Supplement: Nicotinamide Riboside Other: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: June 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotinamide Riboside
1000mg (2x250mg tablets twice daily)
Dietary Supplement: Nicotinamide Riboside
Placebo Comparator: Placebo
Two tablets twice daily
Other: Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 80 Years   (Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02950441


Contacts
Contact: Yasir Elhassan, MRCP +441214158705 y.mohamedelhassan@bham.ac.uk
Contact: Gareth Lavery, PhD +441214143917 g.g.lavery@bham.ac.uk

Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Yasir Elhassan, MRCP    +441214158705    y.mohamedelhassan@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham
Investigators
Principal Investigator: Gareth Lavery, PhD Institute of Metabolism and Systems Research, University of Birmingham
  More Information

Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02950441     History of Changes
Other Study ID Numbers: RG_15-152
First Submitted: October 25, 2016
First Posted: November 1, 2016
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
Metabolism

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents