NCT04220658暂停不适用
The NAD+ Baseline Study: a Biomarker-based Study to Evaluate Correlations Between Epigenetic Aging and NAD+ Levels in Healthy Volunteers
Elysium Health1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels
研究概览
简要总结
This is a single center, prospective study to evaluate correlations between epigenetic aging (as measured via DNA methylation) and NAD+ levels in healthy volunteers.
详细描述
This biomarker study consists of a single outpatient visit to the research unit. At this visit, eligibility will be assessed and biomarker samples (blood, saliva and urine) will be collected from subjects meeting eligibility criteria. Consenting subjects with clinically significant screening lab values may be excluded from the study after biomarker sample collection (i.e., clinical lab test results will become available after the biomarker sample collection). The prescribing of drugs to humans will not be part of this protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between 25 - 80 (inclusive) years of age
- •Able and willing to provide written consent, follow instructions to complete study questionnaire(s) and assessments
- •Peripheral venous access sufficient for blood draw
排除标准
- •History of any significant chronic disease including renal, liver, endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic, or metabolic disease, unless well controlled (defined as stable medication regimen) for at least 90 days prior to screening. Clinical significance of active disease will be assessed by the Qualified Investigator to determine eligibility.
- •Clinically significant, unstable or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease that required a change in management or hospitalization within the last 90 days.
- •Subjects with or who have recently experienced a traumatic injury, infections or undergone major surgery at the discretion of the Qualified Investigator
- •Donation or receipt of blood products within 90 days.
- •Clinically significant vital sign or physical examination abnormality at the discretion of the Qualified Investigator.
- •Subjects with history of pellagra or niacin deficiency
- •Alcohol use >2 standard alcoholic drinks per day within the past month
- •History of alcoholism or drug abuse within 1 year prior to screening
- •Use of medical marijuana or products containing cannabinoids in the 14 days prior to screening.
- •Use of lipid lowering agents (including fish oil) unless the dose has been stable for greater than 90 days prior to screening.
- •Use of natural health products containing nicotinamide riboside or niacin exceeding the RDA (16mg/day for males and 14mg/day for females) within 14 days prior to Screening. Potential participants will be asked to bring all supplements for evaluation at time of screening.
- •History of or current diagnosis of any cancer (except for successfully treated basal or squamous cell carcinoma of the skin) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission and more than 5 years after diagnosis are acceptable.
- •Has participated in any clinical trial with an investigational medicinal product within the past two months prior to the first dose in the current study
- •Clinically significant abnormal laboratory results at screening
- •Any other condition which in the Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
- •Consumption of non-water beverage or food within approximately 8 hours of sample collection
结局指标
主要结局
Correlation between biological age, calculated using DNA isolated from blood, and circulating NAD+ levels
时间窗: At baseline
次要结局
- Correlations between biological age, calculated using DNA isolated from saliva, and circulating NAD+ levels(At baseline)
- Correlations between biological age, calculated using DNA isolated from blood and saliva, and Omega-3 levels in blood(At baseline)
研究者
研究点 (1)
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