Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype

NCT ID: NCT02950441

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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-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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nicotinamide Riboside

1000mg (2x250mg tablets twice daily)

Group Type EXPERIMENTAL

Nicotinamide Riboside

Intervention Type DIETARY_SUPPLEMENT

Placebo

Two tablets twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Nicotinamide Riboside

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gareth Lavery, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Metabolism and Systems Research, University of Birmingham

Locations

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University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Yasir Elhassan, MRCP

Role: CONTACT

+441214158705

Gareth Lavery, PhD

Role: CONTACT

+441214143917

Facility Contacts

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Yasir Elhassan, MRCP

Role: primary

+441214158705

Other Identifiers

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RG_15-152

Identifier Type: -

Identifier Source: org_study_id

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