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

This study is currently recruiting participants.
Verified August 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03151239
First Posted: May 12, 2017
Last Update Posted: August 3, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in women.

Condition Intervention
Glucose Metabolism Disorders Dietary Supplement: NMN supplement Other: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 50
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: June 1, 2020
Estimated Primary Completion Date: June 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women 55-70 years old
  • BMI 25.0-34.9 kg/m2
  • Dyslipidemia (triglyceride ≥150 mg/dl and HDL-cholesterol <50 mg/dl), 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.
  Contacts and Locations
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
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03151239     History of Changes
Other Study ID Numbers: 201701096
First Submitted: May 8, 2017
First Posted: May 12, 2017
Last Update Posted: August 3, 2017
Last Verified: August 2017

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