Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT03151707
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Dost Ongur, Mclean Hospital

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Nicotinamide Riboside Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide riboside 2g/day Drug: Nicotinamide Riboside
Nicotinamide riboside 2g/day




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151707


Contacts
Layout table for location contacts
Contact: Cagri Yuksel 617 855 2779 ayuksel@partners.org
Contact: Lauren Watford 617 855 2540 lwatford@partners.org

Locations
Layout table for location information
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Lauren Watford    617-855-2540    lwatford@partners.org   
Sub-Investigator: Cagri Yuksel, MD         
Principal Investigator: Dost Ongur, MD, PhD         
Sponsors and Collaborators
Mclean Hospital
Layout table for additonal 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    
Other Study ID Numbers: 2017P000006
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021

Layout table for additional information
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:
Layout table for MeSH terms
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents