Nicotinamide Riboside and Brain Energy in Healthy Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label study using high-dose nicotinamide riboside to examine in vivo brain NAD+ and NADH levels and bioenergetic function. Participants will undergo phosphorus-31 MR spectroscopy at 7 Tesla before and after two weeks of NR treatment, serving as their own controls. The primary outcome is the NAD+ to NADH ratio in the brain, with secondary measures of overall brain energy metabolism. Up to 40 medically and psychiatrically healthy adults will be enrolled after screening for eligibility and safety. Exclusions include significant medical conditions, pregnancy, MRI contraindications, and current use of most medications or supplements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (between 18 and 65 years old)
2. Without a current psychiatric diagnosis assessed by a structured psychiatric interview at the screening/consent visit
3. Without a history of a psychotic disorder and/or mood disorder among parents, siblings, or children

Exclusion Criteria:

1. Any current significant medical or neurological illness.
2. Diagnosis of diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, and uncontrolled peptic ulcer disease.
3. Currently taking any other medications, including over-the-counter supplements except oral contraceptives for women and Tylenol as needed for pain or headache.
4. Currently pregnant or breastfeeding. Females of child-bearing age must be using an effective contraceptive method.
5. History of 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 IUDs)
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.

Where it's running

• Dauten Family Center for Bipolar Treatment Innovation
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Mohamed A Soliman, MD, MBA, PHD
• Email: msoliman5@mgb.org
• Phone: 617-726-5855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.