Clinical trial

The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics

Name
2017P000006
Description
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.
Trial arms
Trial start
2017-10-01
Estimated PCD
2022-09-30
Trial end
2022-09-30
Status
Terminated
Phase
Early phase I
Treatment
Nicotinamide Riboside
Nicotinamide riboside 2g/day for a 2 week duration
Arms:
Nicotinamide riboside 2g/day
Size
11
Primary endpoint
Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
Baseline and after 15 days of supplement use
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2024-03-05

1 organization

1 product

1 indication

Organization
Mclean Hospital
Indication
Healthy