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Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function (NMN)

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ClinicalTrials.gov Identifier: NCT03151239
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in women.

Condition or disease Intervention/treatment Phase
Glucose Metabolism Disorders Dietary Supplement: NMN supplement Other: Placebo Not Applicable

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 (a) the hormone insulin works to control blood sugar, (b) the body produces insulin, and (c) blood vessels dilate (get wider). 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Intervention will last 8 weeks in the form of two capsules.
Experimental: NMN supplementation Dietary Supplement: NMN supplement
Intervention will last 8 weeks in the form of two capsules (250 mg total).
Other Name: nicotinamide mononucleotide



Primary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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 or HbA1C ≥5.7%

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.

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): NCT03151239


Contacts
Contact: Sally Torbitzky, BSN 314-362-9950 storbitz@wustl.edu
Contact: Mihoko Yoshino, MD 314-362-8228 myoshino@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sally Torbitzky, RN, BSN    314-362-9950    storbitz@wustl.edu   
Contact: Mihoko Yoshino, MD    314-362-8228    myoshino@wustl.edu   
Principal Investigator: Samuel Klein, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03151239     History of Changes
Other Study ID Numbers: 201701096
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Metabolic Diseases
Glucose Metabolism Disorders
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents