NCT04571008

Brief Summary

The goal of this proposal is to determine whether the beneficial effects of NMN on metabolic function observed in rodents applies to people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2025

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

September 24, 2020

Results QC Date

January 6, 2026

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Muscle Insulin Sensitivity

    The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion after intervention period.

    After at least 16 weeks of treatment

Secondary Outcomes (1)

  • Changes in Glucose Tolerance

    After at least 16 weeks of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

At least 16 weeks of placebo.

Other: Placebo

NMN supplementation

EXPERIMENTAL

At least 16 weeks of NMN.

Dietary Supplement: Treatment

Interventions

PlaceboOTHER

Intervention will last at least 16 weeks in the form of two capsules.

Placebo
TreatmentDIETARY_SUPPLEMENT

Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day).

NMN supplementation

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25.0-50.0 kg/m²
  • Prediabetes defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7, or HOMA-IR ≥2.5.

You may not qualify if:

  • Women who are still having menses
  • Persons who take niacin, nicotinamide, or other vitamin B3-related supplementation and are not willing to discontinue supplementation for 3 weeks before medical screening and during the entire study period
  • Persons who consume moderate-large amounts of caffeine daily (\>2 cups of coffee or 8 oz caffeinated drinks per day) or consume less amounts of caffeine but believe withdrawal symptoms (e.g. headache) are likely if caffeine is stopped
  • Unstable weight (\>3% change during the last 2 months before entering the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Sarah Farabi
Organization
Washington University in St. Louis

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

October 1, 2020

Primary Completion

March 4, 2025

Study Completion

March 4, 2025

Last Updated

March 11, 2026

Results First Posted

March 11, 2026

Record last verified: 2026-03

Locations