NCT02950441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 7, 2017

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

October 25, 2016

Last Update Submit

June 5, 2017

Conditions

Aging

Keywords

Nicotinamide RibosideNicotinamide Adenine DinucleotideSkeletal muscleMetabolism

Outcome Measures

Primary Outcomes (2)

  • Mitochondrial function assessment in skeletal muscle using high resolution respirometry

    Mitochondrial function assessment on muscle biopsies using high resolution respirometry

    Following 3 weeks of NR supplementation

  • Skeletal muscle NAD+ levels in vastus lateralis biopsy using targeted metabolomics

    Following 3 weeks of NR supplementation

Secondary Outcomes (7)

  • Improvement in response to oral glucose tolerance test/HOMA-IR

    Following 3 weeks of NR supplementation

  • Improvement in lipid profile

    Following 3 weeks of NR supplementation

  • Muscle Arterio-Venous Difference - Tissue-specific metabolite trafficking, oxygen consumption and CO2 production

    Following 3 weeks of NR supplementation

  • Muscle biopsy: adaptive expression profile (genomic)

    Following 3 weeks of NR supplementation

  • Changes in resting metabolic rate using indirect calorimetry

    Following 3 weeks of NR supplementation

  • +2 more secondary outcomes

Study Arms (2)

Nicotinamide Riboside

EXPERIMENTAL

1000mg (2x250mg tablets twice daily)

Dietary Supplement: Nicotinamide Riboside

Placebo

PLACEBO COMPARATOR

Two tablets twice daily

Other: Placebo

Interventions

Nicotinamide RibosideDIETARY_SUPPLEMENT
Nicotinamide Riboside
PlaceboOTHER
Placebo

Eligibility Criteria

Age70 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

  • Gareth Lavery, PhD

    Institute of Metabolism and Systems Research, University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasir Elhassan, MRCP

CONTACT

+441214158705y.mohamedelhassan@bham.ac.uk

Gareth Lavery, PhD

CONTACT

+441214143917g.g.lavery@bham.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 1, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

June 7, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)