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 : September 11, 2020
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Nicotinamide riboside 1000 mg/day |
Drug: Nicotinamide Riboside
Nicotinamide riboside 1000 mg/day |
- 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
- 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

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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 |
Inclusion Criteria:
- Age: 18-65 year-old
- Male or female
- Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
- Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.
Exclusion Criteria:
- Significant medical or neurological illness.
- 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.
- Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
- Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
- History of smoking, substance abuse or dependence.
- 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)
- Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
- Difficulty in swallowing capsules.

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
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 |
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: | September 11, 2020 |
Last Verified: | September 2020 |
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 |
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 |