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Effect of NMN Supplementation on Organ System Biology (VAN)

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ClinicalTrials.gov Identifier: NCT04571008
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine

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
Glucose Metabolism Disorders Other: Placebo Dietary Supplement: Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571008


Contacts
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Contact: Ashley Roberts 314-273-1879 nutritionresearch@wustl.edu
Contact: Sally Torbitzky 314-362-9950 storbitz@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sally Torbitzky, RN, BSN    314-362-8529    storbitz@wustl.edu   
Principal Investigator: Samuel Klein, MD         
Sub-Investigator: Mihoko Yoshino, MD PhD         
Sponsors and Collaborators
Washington University School of Medicine
United States Department of Defense
Investigators
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Principal Investigator: Samuel Klein, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04571008    
Other Study ID Numbers: 201909118
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders