Effect of NMN Supplementation on Organ System Biology

NCT ID: NCT04571008

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2025-03-04

Brief Summary

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

Detailed Description

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This study is looking at the effect of the dietary supplement "Nicotinamide mononucleotide" (NMN) on key cardiovascular and metabolic functions, specifically those that are important risk factors for diabetes and cardiovascular disease.

Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

At least 16 weeks of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

NMN supplementation

At least 16 weeks of NMN.

Group Type EXPERIMENTAL

Treatment

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

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

Intervention Type OTHER

Treatment

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201909118

Identifier Type: -

Identifier Source: org_study_id

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