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Trial record 1 of 2 for:    nicotinamide mononucleotide, nmn
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Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function (NMN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151239
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
To determine change in insulin sensitivity. [ Time Frame: at least 8 weeks ]
This will be determined by observing skeletal muscle insulin sensitivity (assessed by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope tracer infusion).
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • To determine change in insulin sensitivity. [ Time Frame: 2 years ]
    This will be determined by observing liver and skeletal muscle insulin sensitivity (assessed by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope tracer infusion).
  • To determine change in beta-cell function. [ Time Frame: 2 years ]
    This will be determined by looking at β-cell function (assessed by using the frequently sampled intravenous glucose tolerance test).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function
Official Title  ICMJE Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
Brief Summary The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in women.
Detailed Description This study is 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. Accordingly, the investigators will evaluate the effect of NMN on how well the hormone insulin works to control blood sugar. The investigators will also look at the effects of NMN on blood lipids; body fat and liver fat; and other blood, fat tissue and muscle tissue markers of cardiovascular (heart) and metabolic health. Data from studies conducted in rodents have shown that NMN supplementation has beneficial effects on cardiovascular and metabolic health, but this has not yet been studied in people.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Glucose Metabolism Disorders
Intervention  ICMJE
  • Dietary Supplement: NMN supplement
    Intervention will last at least 8 weeks in the form of two capsules (250 mg total).
    Other Name: nicotinamide mononucleotide
  • Other: Placebo
    Intervention will last at least 8 weeks in the form of two capsules.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: NMN supplementation
    Intervention: Dietary Supplement: NMN supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 10, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2017)
50
Estimated Study Completion Date  ICMJE May 30, 2021
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women 55-75 years old
  • BMI 25.0-44.9 kg/m²
  • Fasting plasma glucose concentration ≥100 mg/dl, OGTT 2 hour glucose ≥ 140 mg/dl, HbA1C ≥5.7%, or HOMA-IR ≥2.5

Exclusion Criteria:

  • Diabetes
  • Premenopausal or menopause <1 year
  • Persons who have received hormone replacement therapy within the past 6 months
  • Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
  • Structured exercise: ≥75 min/wk of vigorous exercise (e.g., jogging, activity that causes heavy breathing and sweating) or ≥150 min/wk of low intensity physical activity (e.g., brisk walking).
  • Unstable weight (>3% change during the last 2 months before entering the study)
  • Significant organ system dysfunction or disease
  • Present cancer or history of cancer that has been in remission for <5 years
  • Polycystic ovary syndrome
  • Major psychiatric illness
  • Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study
  • Metal implants
  • Smokes cigarettes
  • Persons who consume >14 units of alcohol per week
  • Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03151239
Other Study ID Numbers  ICMJE 201701096
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP