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 : December 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Glucose Metabolism Disorders||Other: Placebo Dietary Supplement: Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|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|
Placebo Comparator: Placebo
At least 16 weeks of 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).
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||45 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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)
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
|Contact: Ashley Robertsemail@example.com|
|Contact: Sally Torbitzkyfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Sally Torbitzky, RN, BSN 314-362-8529 email@example.com|
|Principal Investigator: Samuel Klein, MD|
|Sub-Investigator: Mihoko Yoshino, MD PhD|
|Principal Investigator:||Samuel Klein, MD||Washington University School of Medicine|
|Responsible Party:||Washington University School of Medicine|
|Other Study ID Numbers:||
|First Posted:||September 30, 2020 Key Record Dates|
|Last Update Posted:||December 8, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Glucose Metabolism Disorders