Effect of NMN Supplementation on Organ System Biology (VAN)

June 12, 2023 updated by: Washington University School of Medicine

Effect of Nicotinamide Mononucleotide (NMN) Supplementation on Organ System Biology

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Samuel Klein, MD
        • Sub-Investigator:
          • Gordon Smith, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
At least 16 weeks of placebo.
Other: Placebo
Intervention will last at least 16 weeks in the form of two capsules.
Experimental: NMN supplementation
At least 16 weeks of NMN.
Dietary supplement: Treatment
Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Muscle insulin sensitivity
Time Frame: before and after at least 16 weeks of treatment
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
before and after at least 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in glucose tolerance
Time Frame: before and after at least 16 weeks of treatment
The outcome will be assessed during modified oral glucose tolerance test
before and after at least 16 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Samuel Klein, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201909118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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