The Effects of IV Administration of ChromaDex's Niagen®, Nicotinamide Riboside Chloride as Compared to IV Administration of NAD+: A Randomized, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV.
详细描述
The purpose of this work is to establish and quantify the safety and efficacy of IV administration of ChromaDex's Niagen®, nicotinamide riboside chloride in comparison to currently available IV NAD+, a saline IV, and orally administered Niagen®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
- •Lives within 100 miles of a NRI study site
- •Any gender, aged 40+ (For the 5th arm, only males will be evaluated.)
- •Good general health as evidenced by medical history
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
- •Agreement to adhere to Lifestyle Considerations throughout study duration
排除标准
- •Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, cancer, or Parkinson's disease,
- •Pregnancy, trying to conceive, or breastfeeding
- •Known allergic reactions to any components of the intervention
- •Positive COVID-19 test within 30 days of the study period
- •Recent dramatic weight changes (10% change in body weight in the last 6 months)
- •Existing usage of a NAD+ or NAD precursor supplement in any form.
- •Introducing a new investigational drug or other intervention within 30 days before the start of the study
结局指标
主要结局
Glucose
时间窗: baseline, at 3 hours, and 24 hours post administration of intervention
Total glucose in blood via mg/dL
total NAD measured through blood and plasma
时间窗: baseline, at 3 hours, and 24 hours post administration of intervention
NAD analysis conducted on whole blood and plasma samples
Blood Pressure
时间窗: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
blood pressure, systolic and diastolic, will be measured
Total NAD measured through dried blood spot testing
时间窗: Blood spot data is collected at baseline, immediately after the intervention, 3 hours after the intervention, 6 hours after the intervention,on day 2, 7, and 14.
NAD analysis will be developed from dried blood spots obtained by pricking a finger
Heart rate
时间窗: immediately before the intervention, immediately after the intervention, 3 and 6 hours post-intervention, and at the 24 hour visit.
heart rate will be measured
Tolerable Infusion Rate
时间窗: through intervention completion, an average of 2 hours
The total amount of time it takes patients to comfortably receive the IV
Insulin Levels
时间窗: baseline, at 3 hours, and 24 hours post administration of intervention
Total insulin in blood via mcU/mL
次要结局
- Energy Scale(Change from baseline at day 14)
- Complete Blood Count(baseline, at 3 hours, and 24 hours post administration of intervention)
- Comprehensive Metabolic Panel(baseline, at 3 hours, and 24 hours post administration of intervention)
- Sleep Scale(Change from baseline at day 14)