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

This study is not yet open for participant recruitment.
Verified August 2017 by Dost Ongur, Mclean Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03151707
First Posted: May 12, 2017
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dost Ongur, Mclean Hospital
  Purpose

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 aim is to investigate the effects of NR on brain structure and neurotransmitter functions using other neuroimaging methods.


Condition Intervention Phase
Healthy Drug: Nicotinamide Riboside Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics

Resource links provided by NLM:


Further study details as provided by Dost Ongur, Mclean Hospital:

Primary Outcome Measures:
  • Change from baseline to the end of treatment in brain NAD+/NADH ratio [ Time Frame: Baseline to 2 weeks ]
    Change from baseline to the end of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy


Secondary Outcome Measures:
  • Change from baseline to the end of treatment in brain phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) [ Time Frame: Baseline to 2 weeks ]
    Change from baseline to the end of treatment in brain adenosine triphosphate (ATP) and phosphocreatine (PCr) levels as measured by in vivo 31P magnetic resonance spectroscopy

  • Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate [ Time Frame: Baseline to 2 weeks ]
    Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy


Estimated Enrollment: 60
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotinamide riboside 1000 mg/day Drug: Nicotinamide Riboside
Nicotinamide riboside 1000 mg/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18-65 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dost Ongur, Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03151707     History of Changes
Other Study ID Numbers: 2017P000006
First Submitted: May 4, 2017
First Posted: May 12, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents