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

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders
• Interventions: Other: Placebo; Dietary Supplement: NMN supplement

• Registration Number: NCT03151239
• Lead Sponsor: 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 people.

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 Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Study Start: 2017-07-01
• Primary Completion: 2019-05-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
NMN supplementation	NMN supplement	-

Primary Outcome Measures

Name	Time	Method
Change in muscle insulin sensitivity	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

Name	Time	Method
Changes in liver insulin sensitivity	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.
Change in body fat mass	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.
Changes in tissue NAD content	before and after at least 8 weeks of treatment	The outcome will be assessed by measuring NAD content before and after intervention period
Change in fat free mass	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.
Changes in intra-abdominal adipose tissue volume	before and after at least 8 weeks of treatment	The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Changes in intrahepatic triglyceride content	before and after at least 8 weeks of treatment	The outcome will be measured by using magnetic resonance imaging before and after intervention period.
Changes in plasma glucose concentration	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.
Change in adipose tissue insulin sensitivity	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.
Changes in blood pressure	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.
Changes in fasting insulin	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.
Changes in fasting free fatty acid	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.
Changes in protein levels in skeletal muscle insulin signaling	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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States