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

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ClinicalTrials.gov Identifier: NCT03151707
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dost Ongur, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
  • Change from baseline to 6 hours after first dose of treatment in brain NAD+/NADH ratio [ Time Frame: Baseline to 6 hours after first dose ]
    Change from baseline to 6 hours after first dose of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
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
Change History Complete list of historical versions of study NCT03151707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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 n 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 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
  • Change from baseline to 6 hours after first dose of treatment in brain phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) [ Time Frame: Baseline to 6 hours after first dose ]
    Change from baseline to 6 hours after first dose 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 6 hours after first dose of treatment in brain creatine kinase (CK) enzyme rate [ Time Frame: Baseline to 6 hours after first dose ]
    Change from baseline to 6 hours after first dose of treatment in brain creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Nicotinamide Riboside Supplementation on NAD+/NADH Ratio and Bioenergetics
Official Title  ICMJE The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics
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 aim is to investigate the effects of NR on brain structure and neurotransmitter functions using other neuroimaging methods.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Nicotinamide Riboside
Nicotinamide riboside 1000 mg/day
Study Arms  ICMJE Experimental: Nicotinamide riboside 1000 mg/day
Intervention: Drug: Nicotinamide Riboside
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03151707
Other Study ID Numbers  ICMJE 2017P000006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dost Ongur, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mclean Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP