Trial record 9 of 951 for:
The Effects of Nicotinamide Riboside Supplementation on NAD+/NADH Ratio and Bioenergetics
Verified May 2017 by Dost Ongur, Mclean Hospital
Information provided by (Responsible Party):
Dost Ongur, Mclean Hospital
First received: May 4, 2017
Last updated: May 11, 2017
Last verified: May 2017
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.
Drug: Nicotinamide Riboside
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics
Primary Outcome Measures:
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:
| Anticipated Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2019 (Final data collection date for primary outcome measure)
Experimental: Nicotinamide riboside 1000 mg/day
Drug: Nicotinamide Riboside
Nicotinamide riboside 1000 mg/day
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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||Dost Ongur, Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School, Mclean Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 4, 2017
||May 11, 2017
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
|Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2017
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