Clinical trial NCT03151707: The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics
Official title: The Effects of Nicotinamide Riboside Supplementation on Nicotinamide Adenine Dinucleotide (NAD+/NADH) Ratio and Bioenergetics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
timeFrame: Baseline and after 15 days of supplement use
Secondary outcomes:
measure: Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
timeFrame: Baseline and after 15 days of supplement use
measure: Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate
timeFrame: Baseline and after 15 days of supplement use
measure: Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio
timeFrame: Baseline and after 15 days of supplement use
measure: Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
timeFrame: Baseline and after 15 days of supplement use
measure: Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate
timeFrame: Baseline and after 15 days of supplement use
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Dost Ongur, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: