VAN: Effect of NMN Supplementation on Organ System Biology

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04571008
Collaborator
United States Department of Defense (U.S. Fed)
56
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2
59
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Placebo
  • Dietary Supplement: Treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of Nicotinamide Mononucleotide (NMN) Supplementation on Organ System Biology
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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 NMN capsules (total of 300 mg/day).

Outcome Measures

Primary Outcome Measures

  1. Change in Muscle insulin sensitivity [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.

Secondary Outcome Measures

  1. Changes in glucose tolerance [before and after at least 16 weeks of treatment]

    The outcome will be assessed during modified oral glucose tolerance test

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • BMI 25.0-34.9 kg/m²

  • Prediabetes defined as a 2-h oral glucose tolerance test plasma glucose of 140-199 mg/dL with or without a fasting plasma glucose of 100-125 mg/dL, or HbA1C ≥5.7.

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • United States Department of Defense

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04571008
Other Study ID Numbers:
  • 201909118
First Posted:
Sep 30, 2020
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021