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

Overview

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.

Full Title of Study: “The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2022

Interventions

  • Drug: Nicotinamide Riboside
    • Nicotinamide riboside 2g/day for a 2 week duration

Arms, Groups and Cohorts

  • Experimental: Nicotinamide riboside 2g/day
    • Participants will receive NR at a dose of 2g/day

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
    • Time Frame: Baseline and after 15 days of supplement use
    • 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.

Secondary Measures

  • Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
    • Time Frame: Baseline and after 15 days of supplement use
    • Change from baseline to the end of treatment in brain phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) as measured by in vivo 31P magnetic resonance spectroscopy
  • Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate
    • Time Frame: Baseline and after 15 days of supplement use
    • Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy
  • Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio
    • Time Frame: Baseline and after 15 days of supplement use
    • Change from baseline to the end of treatment in calf muscle NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
  • Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
    • Time Frame: Baseline and after 15 days of supplement use
    • Change from baseline to the end of treatment in calf muscle phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) as measured by in vivo 31P magnetic resonance spectroscopy
  • Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate
    • Time Frame: Baseline and after 15 days of supplement use
    • Change from baseline to the end of treatment in calf muscle creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 18-80 year-old 2. Male or female 3. Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID)) 4. Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only. Exclusion Criteria:

1. Significant medical or neurological illness. 2. 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. 3. Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women 4. Pregnancy. Females of child-bearing age must be using an effective contraceptive method. 5. History of smoking, substance abuse or dependence. 6. 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) 7. Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids). 8. Difficulty in swallowing capsules.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mclean Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dost Ongur, Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School – Mclean Hospital
  • Overall Official(s)
    • Dost Ongur, MD PhD, Principal Investigator, Mclean Hospital

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