Clinical trial NCT03151239: Effect of "Nicotinamide Mononucleotide" (NMN) on Cardiometabolic Function
Official title: Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Change in muscle insulin sensitivity
timeFrame: before and after at least 8 weeks of treatment
Secondary outcomes:
measure: Changes in liver insulin sensitivity
timeFrame: before and after at least 8 weeks of treatment
measure: Change in adipose tissue insulin sensitivity
timeFrame: before and after at least 8 weeks of treatment
measure: Change in body fat mass
timeFrame: before and after at least 8 weeks of treatment
measure: Change in fat free mass
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in intra-abdominal adipose tissue volume
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in intrahepatic triglyceride content
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in blood pressure
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in plasma glucose concentration
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in fasting insulin
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in fasting free fatty acid
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in tissue NAD content
timeFrame: before and after at least 8 weeks of treatment
measure: Changes in protein levels in skeletal muscle insulin signaling
timeFrame: before and after at least 8 weeks of treatment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.