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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 : Completed
First Posted : May 12, 2017
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Change in muscle insulin sensitivity [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be assessed by hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.


Secondary Outcome Measures :
  1. Changes in liver insulin sensitivity [ Time Frame: before and after at least 8 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.

  2. Change in adipose tissue insulin sensitivity [ Time Frame: before and after at least 8 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.

  3. Change in body fat mass [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.

  4. Change in fat free mass [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.

  5. Changes in intra-abdominal adipose tissue volume [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be measured by using magnetic resonance imaging before and after intervention period.

  6. Changes in intrahepatic triglyceride content [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be measured by using magnetic resonance imaging before and after intervention period.

  7. Changes in blood pressure [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be assessed by measuring blood pressure at rest before and after intervention period.

  8. Changes in plasma glucose concentration [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be determined by plasma glucose concentration after overnight fasting, before and after intervention period.

  9. Changes in fasting insulin [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be determined by plasma insulin concentration after overnight fasting, before and after intervention period.

  10. Changes in fasting free fatty acid [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be determined by plasma free fatty acid concentration after overnight fasting, before and after intervention period.

  11. Changes in tissue NAD content [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be assessed by measuring NAD content before and after intervention period

  12. Changes in protein levels in skeletal muscle insulin signaling [ Time Frame: before and after at least 8 weeks of treatment ]
    The outcome will be determined by Western blot by using samples collected before and after intervention period


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
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, 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.
Contacts and Locations
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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


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Samuel Klein, MD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03151239    
Other Study ID Numbers: 201701096
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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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
Niacinamide
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs