The Effect of Oral Nicotinamide Riboside on Systemic Vascular Perfusion in Healthy Adults: A Critical Foundation of Cerebrovascular Health, Cardiovascular Health, and Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Participants with Reduced Endothelial Stiffness
研究概览
简要总结
The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults.
详细描述
This study is a randomized, double-blind, placebo-controlled, parallel-dose clinical trial. Participants will be randomly assigned to one of three groups. Study measurements will be completed at three timepoints and intervention taken daily throughout the subject's 12 weeks of participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The pharmacy will be responsible for randomization and dispensing appropriate randomized intervention.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>= 35 and <=70
- •Provides consent to participate in the study
- •Not pregnant at time of consent
- •Understands and agrees to follow all study procedures and limitations
- •Have no contraindicating comorbid health condition as determined by the clinical investigators
排除标准
- •Pregnant, nursing, or trying to conceive
- •BMI Restrictions: <35
- •Allergy or sensitivity to study agent ingredients
- •Hypertension treated with medication
- •Use of natural health products containing nicotinamide riboside, quercetin, trans-resveratrol, or betaine anhydrous within 7 days prior to randomization and during the course of the study.
- •Surgery planned during the course of the trial
- •History or past diagnosis of chronic diseases, unstable medical conditions, blood/bleeding disorders or stroke
- •History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis.
- •Abnormal blood chemistries for renal or liver function (defined as 1 standard deviation outside of the normal range), alcohol dependence, uncontrolled thyroid disease, severe obesity (body mass index >40 kg m-2), or weight stable for at least 3 months prior to enrolling in the study (defined as >2 kg change in body mass).
- •An unstable medical or mental health condition as determined by the physician investigator.
研究组 & 干预措施
Placebo
2 identical Placebo capsules twice a day for 12 weeks
干预措施: Placebo (Other)
830 mg Nicotinamide and Placebo
830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks
干预措施: Nicotinamide Riboside Malate (Dietary Supplement)
830 mg Nicotinamide and Placebo
830 mg Nicotinamide supplement capsule and 1 identical Placebo capsule twice a day for 12 weeks
干预措施: Placebo (Other)
1660 mg Nicotinamide
1660 mg Nicotinamide supplement; 2 of the 830 mg capsules twice a day for 12 weeks
干预措施: Nicotinamide Riboside Malate (Dietary Supplement)
结局指标
主要结局
Number of Participants with Reduced Endothelial Stiffness
时间窗: Baseline to End of study at 12 weeks
Endothelial Peripheral Arterial Tonometry testing will be used to assess endothelial stiffness changes over study
次要结局
未报告次要终点
研究者
Ryan T. Hurt, M.D., Ph.D.
Principle Investigator
Mayo Clinic