Effect of NMN (Nicotinomide Mononucleotide) Supplementation on Cardiometabolic Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in muscle insulin sensitivity
研究概览
简要总结
The purpose of the study is to understand the effect of the dietary supplement "Nicotinamide mononucleotide" on metabolic health in people.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in muscle insulin sensitivity
时间窗: 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.
次要结局
- Changes in plasma glucose concentration(before and after at least 8 weeks of treatment)
- Changes in liver insulin sensitivity(before and after at least 8 weeks of treatment)
- Change in body fat mass(before and after at least 8 weeks of treatment)
- Changes in tissue NAD content(before and after at least 8 weeks of treatment)
- Change in fat free mass(before and after at least 8 weeks of treatment)
- Changes in intra-abdominal adipose tissue volume(before and after at least 8 weeks of treatment)
- Changes in intrahepatic triglyceride content(before and after at least 8 weeks of treatment)
- Change in adipose tissue insulin sensitivity(before and after at least 8 weeks of treatment)
- Changes in blood pressure(before and after at least 8 weeks of treatment)
- Changes in fasting insulin(before and after at least 8 weeks of treatment)
- Changes in fasting free fatty acid(before and after at least 8 weeks of treatment)
- Changes in protein levels in skeletal muscle insulin signaling(before and after at least 8 weeks of treatment)