Nicotinamide Riboside, Vit B3 Analogue, and Brain Energy Metabolism

NCT07649161 | Recruiting

• 1 other identifier: 2025P003087
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how nicotinamide riboside (NR), a form of vitamin B3, affects brain energy metabolism in healthy adults. Researchers want to find out if taking NR by mouth for 2 weeks can raise the balance of two related brain chemicals called NAD+ and NADH, which play a key role in how cells make and use energy. The main questions are: Does short term NR treatment increase the NAD+ to NADH ratio in the brain, and does it change other brain energy measures that we can see with a special type of MRI scan called phosphorus 31 MR spectroscopy. Adults between 18 and 65 years old who are generally healthy and do not have a personal or close family history of mood or psychotic disorders may be able to take part. People who join the study will first have a screening visit with a psychiatric interview and safety checks to confirm they are eligible and to review the risks and procedures. Eligible participants will then have a baseline visit that includes a blood draw, vital signs, urine drug and pregnancy tests when needed, and a 7 Tesla MRI/MRS scan focused on brain chemistry and structure. After the baseline visit, participants will take NR capsules by mouth at home, 1500 milligrams in the morning and 1500 milligrams in the early afternoon each day, for about 2 weeks, for a total daily dose of 3000 milligrams. They will be asked to avoid alcohol and other drugs during the study and to complete a short food diary near the end of the dosing period so that researchers can track diet. On the last day of taking NR, participants will return for repeat MRI/MRS scans, blood tests, and vital signs so that researchers can compare brain and blood measures before and after NR treatment. Researchers will compare each participant's brain NAD+ to NADH ratio and other bioenergetic markers before and after NR to see if NR changes these measures in a consistent way. If NR raises brain NAD+ and improves measures of energy metabolism in healthy adults, this may provide important background information for future studies that test whether NR can help people with psychiatric or neurological disorders linked to mitochondrial dysfunction and oxidative stress. There is no expected direct health benefit for participants, but their involvement may help improve understanding of how NR affects human brain metabolism.

Conditions

Healthy Adult

Keywords

Nicotinamide riboside supplementation; Vitamin B3 analogs; Nicotinamide adenine dinucleotide metabolism; Brain energy metabolism; Phosphorus 31 magnetic resonance spectroscopy; Brain bioenergetics imaging

Outcome Measures

Primary Outcomes (1)

• Brain NAD+/NADH Ratio

  The investigators will be using a non-invasive Phosphorous Magnetic Resonance Spectroscopy (31P-MRS) to measure NAD+ and NADH levels in the brain.

  Participants will have two brain scans over the course of the study - one at baseline (Day 1) and one at follow up (Day 15)

Secondary Outcomes (10)

• Biomarkers of cellular energy metabolics

  Participants will have two blood draws over the course of the study - one at baseline (Day 1) and one at follow up (Day 15)

• Biomarkers of cellular energy metabolics

  Participants will have two blood draws over the course of the study - one at baseline (Day 1) and one at follow up (Day 15)

• Biomarkers of cellular energy metabolics

  Participants will have two blood draws over the course of the study - one at baseline (Day 1) and one at follow up (Day 15).

• Biomarkers of cellular energy metabolics

  Participants will have two blood draws over the course of the study - one at baseline (Day 1) and one at follow up (Day 15).

• Biomarkers of cellular energy metabolics

  Participants will have their heart rate measured twice throughout the study - once at baseline (Day 1) and once at follow up (Day 15).

Study Arms (1)

Nicotinamide Riboside Supplementation (Single Arm Experimental)

EXPERIMENTAL

Healthy adult volunteers will take 3000 mg of oral nicotinamide riboside (from Niagen) daily for 2 weeks. This will be in the form of six 250 mg capsules taken in the morning and six 250 mg capsules taken at night for a total of 12 capsules daily. All participants undergo baseline and post treatment assessments that include phosphorus 31 MR spectroscopy and MRI at 7 Tesla to measure brain NAD plus and NADH levels and other bioenergetic markers, along with blood draws for NAD related metabolites, vital signs, and safety monitoring. Each participant serves as their own control, and there are no additional study arms or placebo groups in this single arm, open label mechanistic trial.

Dietary Supplement: Niagen®

Interventions

Niagen® DIETARY_SUPPLEMENT

Participants will take 3000 mg of nicotinamide riboside (i.e., Niagen) daily for 2 weeks. This will be in the form of six 250 mg capsules in the morning and six 250 mg capsules at night for a total of 12 capsules daily.

Nicotinamide Riboside Supplementation (Single Arm Experimental)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any current significant medical or neurological illness.
• 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.
• Currently taking any other medications, including over-the-counter supplements except oral contraceptives for women and Tylenol as needed for pain or headache.
• Currently pregnant or breastfeeding. Females of child-bearing age must be using an effective contraceptive method.
• History of 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 IUDs)
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mclean Hospital: collaborator
• Martinos Center for Biomedical Imaging: collaborator

Study Sites (1)

Dauten Family Center for Bipolar Treatment Innovation

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-riboside

Central Study Contacts

Mohamed A Soliman, MD, MBA, PHD

CONTACT

617-726-5855; msoliman5@mgb.org

Bridget Hall, BS

CONTACT

617-643-0049; bhall18@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)