Effect of NMN Supplementation on Organ System Biology

Glucose Metabolism Disorders Clinical Trial

— VAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571008
• Other study ID #: 201909118
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Brittney Mason
• Phone: 314-273-1879
• Email: nutritionresearch[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• Placebo
Intervention will last at least 16 weeks in the form of two capsules.

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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle insulin sensitivity	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	Changes in glucose tolerance	The outcome will be assessed during modified oral glucose tolerance test	before and after at least 16 weeks of treatment