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

Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function

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

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Other: Placebo; Dietary supplement: NMN supplement

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: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: nicotinamide mononucleotide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in liver insulin sensitivity	The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.	before and after at least 8 weeks of treatment
Change in adipose tissue insulin sensitivity	The outcome will be assessed during hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopic tracer infusion before and after intervention period.	before and after at least 8 weeks of treatment
Change in body fat mass	The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.	before and after at least 8 weeks of treatment
Change in fat free mass	The outcome will be measured by using dual-energy X-ray absorptiometry before and after intervention period.	before and after at least 8 weeks of treatment
Changes in intra-abdominal adipose tissue volume	The outcome will be measured by using magnetic resonance imaging before and after intervention period.	before and after at least 8 weeks of treatment
Changes in intrahepatic triglyceride content	The outcome will be measured by using magnetic resonance imaging before and after intervention period.	before and after at least 8 weeks of treatment
Changes in blood pressure	The outcome will be assessed by measuring blood pressure at rest before and after intervention period.	before and after at least 8 weeks of treatment
Changes in plasma glucose concentration	The outcome will be determined by plasma glucose concentration after overnight fasting, before and after intervention period.	before and after at least 8 weeks of treatment
Changes in fasting insulin	The outcome will be determined by plasma insulin concentration after overnight fasting, before and after intervention period.	before and after at least 8 weeks of treatment
Changes in fasting free fatty acid	The outcome will be determined by plasma free fatty acid concentration after overnight fasting, before and after intervention period.	before and after at least 8 weeks of treatment
Changes in tissue NAD content	The outcome will be assessed by measuring NAD content before and after intervention period	before and after at least 8 weeks of treatment
Changes in protein levels in skeletal muscle insulin signaling	The outcome will be determined by Western blot by using samples collected before and after intervention period	before and after at least 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, Sindelar M, Pietka T, Patterson BW, Imai SI, Klein S. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021 Jun 11;372(6547):1224-1229. doi: 10.1126/science.abe9985. Epub 2021 Apr 22.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Niacinamide
• Other Study ID Numbers: 201701096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No