Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype (NADMet)

University of Birmingham

Status and phase: Unknown; Phase 2

Conditions: Aging

Treatments: Dietary Supplement: Nicotinamide Riboside; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02950441

RG_15-152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 70 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Nicotinamide Riboside

Experimental group

Description:

1000mg (2x250mg tablets twice daily)

Treatment:

Dietary Supplement: Nicotinamide Riboside

Placebo

Placebo Comparator group

Description:

Two tablets twice daily

Treatment:

Other: Placebo