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

Glucose Metabolism Disorders Clinical Trial

— NMN  

Official title:

Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151239
• Other study ID #: 201701096
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• NMN supplement
Intervention will last at least 8 weeks in the form of two capsules (250 mg total).

Other:
• Placebo
Intervention will last at least 8 weeks in the form of two capsules.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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