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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

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : July 2019
Estimated Study Completion Date : July 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Nicotinamide riboside 1000 mg/day Drug: Nicotinamide Riboside
Nicotinamide riboside 1000 mg/day


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


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 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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


Locations
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United States, Massachusetts
Cagri Yuksel Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Cagri Yuksel, MD    617-855-2779    ayuksel@partners.org   
Sub-Investigator: Cagri Yuksel, MD         
Principal Investigator: Dost Ongur, MD, PhD         
Sponsors and Collaborators
Mclean Hospital
More Information
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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 Posted: May 12, 2017    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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