Tier 2 — strong

NR-SAFE: a randomized, double-blind safety trial of high dose nicotinamide riboside in Parkinson's disease

Haakon Berven, Simon Kverneng, Erika Sheard, Mona Søgnen, Solveig Amdahl Af Geijerstam, Kristoffer Haugarvoll, Geir-Olve Skeie, Christian Dölle, Charalampos Tzoulis
Nature communications 2023 14(1):7793

Bibliography

PubMed
PMID 38016950
PubMed Central
PMC10684646
DOI
10.1038/s41467-023-43514-6
Funding
Reported funding/support: https://doi.org/10.13039/501100005416Norges Forskningsråd (Research Council of Norway)288164TzoulisCharalampos https://doi.org/10.13039/501100004257Helse Vest (Western Norway Regional Health Authority)F-11470, F-12133TzoulisCharalampos Trond Mohn Foundation (BFS20117REK05)
Competing interests
Reported disclosure: International patent applications relating to the use of nicotinamide riboside as a treatment for Parkinson’s disease have been filed by the Technology Transfer Office “Vestlandets Innovasjonsselskap As (VIS)” on behalf of Haukeland University Hospital, Bergen, Norway, with publication authors C.T. and C.D. as inventors. The applications are pending and have the application numbers: PCT/EP2022/067408, PCT/EP2022/067412 and PCT/EP2023/060962. All other authors declare no competing interests.

Study snapshot

DesignRandomized phase I RCT
ModelHuman participants
Sample20 patients with Parkinson disease
InterventionNicotinamide riboside 1.5 g twice daily versus placebo; no TMG co-supplementation
Duration4 weeks
EndpointsNR safety; NAD metabolome; Homocysteine; Methyl-donor status

What the study showed, in plain terms

Published in 2023, this source examined nad precursors and methyl-donor context. Design: Randomized phase I RCT. Sample/model: 20 patients with Parkinson disease. The exposure or intervention was Nicotinamide riboside 1.5 g twice daily versus placebo; no TMG co-supplementation. Follow-up or treatment period: 4 weeks.

High-dose NR increased NAD-related metabolites and was tolerated in this short study. An initial homocysteine rise occurred without evidence of depletion of the measured methyl-donor pool.

Context for the methylation question only: the trial did not compare NR with versus without TMG, and cannot establish a universal need for TMG or its absence of need at all doses/durations.

Continue with TMG Data Center

Continue with TMG and NMN: Methylation, Dosage Questions and What We Know

Key findings

  • High-dose NR increased NAD-related metabolites and was tolerated in this short study.
  • An initial homocysteine rise occurred without evidence of depletion of the measured methyl-donor pool.
  • The recorded outcome domains were NR safety; NAD metabolome; Homocysteine; Methyl-donor status.
  • The result applies to the tested exposure: Nicotinamide riboside 1.5 g twice daily versus placebo; no TMG co-supplementation; 4 weeks.

What this study can and cannot tell us

  • Context for the methylation question only: the trial did not compare NR with versus without TMG, and cannot establish a universal need for TMG or its absence of need at all doses/durations.
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology