NCT02678611已完成1 期
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
Elysium Health2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 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 60 to 80 (inclusive) years of age
- •Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2)
- ••Be able to make scheduled office visits 4 times during the study
- •Willing to follow the instructions and complete multiple study questionnaires and assessments
- •Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
- •Healthy otherwise as determined by laboratory results and medical history
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined.
- •Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease
- •Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery
- •Subjects with history of pellagra or niacin deficiency
- •Taking lipid lowering drugs
- •Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study
- •History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable
- •Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study
- •Unstable medical conditions
- •Alcohol use >2 standard alcoholic drinks per day
- •History of alcoholism or drug abuse within 1 year prior to screening
- •History of significant allergies
- •Allergy or sensitivity to any of the investigational product ingredients
- •Use of medicinal marijuana
- •Clinically significant abnormal laboratory results at screening
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •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
结局指标
主要结局
Heart Rate
时间窗: 8 weeks
Assessment of heart rate
Blood pressure
时间窗: 8 weeks
Assessment of blood pressure
Safety Blood Parameters
时间窗: 8 weeks
Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)
次要结局
- Body Weight(8 weeks)
- Blood Pressure(8 weeks)
- Lipid Profile(8 weeks)
- Blood NAD+(8 weeks)
- Physiological Performance(8 weeks)
- Quality of Life and Sleep Quality(8 weeks)
- Serum Glucose(8 weeks)
研究者
研究点 (2)
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