The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics

NCT03151707 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2017P000006
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging. The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme rate after NR use. In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured in the calf muscle, as secondary outcome measures.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio

  Change from baseline to the end of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy The NAD+/NADH ratio is calculated by first quantifying NAD+ and NADH separately in the data and then obtaining a simple ratio. There is a normative NAD+/NADH ratio range in healthy brain and deviations from this level in either direction can be a sign of pathology.

  Baseline and after 15 days of supplement use

Secondary Outcomes (5)

• Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)

  Baseline and after 15 days of supplement use

• Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate

  Baseline and after 15 days of supplement use

• Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio

  Baseline and after 15 days of supplement use

• Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)

  Baseline and after 15 days of supplement use

• Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate

  Baseline and after 15 days of supplement use

Study Arms (1)

Nicotinamide riboside 2g/day

EXPERIMENTAL

Participants will receive NR at a dose of 2g/day

Drug: Nicotinamide Riboside

Interventions

Nicotinamide Riboside DRUG

Nicotinamide riboside 2g/day for a 2 week duration

Nicotinamide riboside 2g/day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80 year-old
• Male or female
• Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
• Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.

You may not qualify if:

• Significant medical or neurological illness.
• Diagnosis diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, uncontrolled peptic ulcer disease.
• Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
• Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
• History of smoking, substance abuse or dependence.
• Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal- containing intrauterine devices)
• Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
• Difficulty in swallowing capsules.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Interventions

nicotinamide-beta-riboside

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dost Ongur
• Organization: McLean Hospital

dongur@partners.org

6178553922

Study Officials

• Dost Ongur, MD PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 12, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-03

Locations

US (1)