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Effect of NMN Supplementation on Organ System Biology (VAN)

Primary Purpose

Glucose Metabolism Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Treatment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

NMN supplementation

Arm Description

At least 16 weeks of placebo.

At least 16 weeks of NMN.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in glucose tolerance
The outcome will be assessed during modified oral glucose tolerance test

Full Information

First Posted
September 24, 2020
Last Updated
June 12, 2023
Sponsor
Washington University School of Medicine
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04571008
Brief Title
Effect of NMN Supplementation on Organ System Biology
Acronym
VAN
Official Title
Effect of Nicotinamide Mononucleotide (NMN) Supplementation on Organ System Biology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
At least 16 weeks of placebo.
Arm Title
NMN supplementation
Arm Type
Experimental
Arm Description
At least 16 weeks of NMN.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intervention will last at least 16 weeks in the form of two capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment
Intervention Description
Intervention will last at least 16 weeks in the form of two or three NMN capsules (total of 300 or 450 mg/day).
Primary Outcome Measure Information:
Title
Change in Muscle insulin sensitivity
Description
The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.
Time Frame
before and after at least 16 weeks of treatment
Secondary Outcome Measure Information:
Title
Changes in glucose tolerance
Description
The outcome will be assessed during modified oral glucose tolerance test
Time Frame
before and after at least 16 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Sonnenschein
Phone
314-273-1879
Email
nutritionresearch@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Torbitzky
Phone
314-362-9950
Email
storbitz@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Torbitzky, RN, BSN
Phone
314-362-8529
Email
storbitz@wustl.edu
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
First Name & Middle Initial & Last Name & Degree
Gordon Smith, PhD

12. IPD Sharing Statement

Learn more about this trial

Effect of NMN Supplementation on Organ System Biology

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