A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. (15BSHE)
2016年7月28日 更新者:Elysium Health
A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects.
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.
研究概览
研究类型
介入性
注册 (实际的)
120
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ontario
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London、Ontario、加拿大、N6A 5R8
- KGK Synergize Inc.
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:安慰剂
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实验性的:Basis 250
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实验性的:Basis 500
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood pressure
大体时间:8 weeks
|
Assessment of blood pressure
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8 weeks
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Safety Blood Parameters
大体时间:8 weeks
|
Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)
|
8 weeks
|
|
Heart Rate
大体时间:8 weeks
|
Assessment of heart rate
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
血压
大体时间:8周
|
8周
|
|
|
Physiological Performance
大体时间:8 weeks
|
6 Minute Walk Test
|
8 weeks
|
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Physiological Performance
大体时间:8 weeks
|
30 Second Chair Stand Test
|
8 weeks
|
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Physiological Performance
大体时间:8 weeks
|
Physical Activity Scale for the Elderly
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8 weeks
|
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Body Weight
大体时间:8 weeks
|
8 weeks
|
|
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Serum Glucose
大体时间:8 weeks
|
8 weeks
|
|
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Lipid Profile
大体时间:8 weeks
|
8 weeks
|
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Quality of Life and Sleep Quality
大体时间:8 weeks
|
Health Assessment Questionnaire
|
8 weeks
|
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Quality of Life and Sleep Quality
大体时间:8 weeks
|
Older People's Quality of Life Questionnaires
|
8 weeks
|
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Blood NAD+
大体时间:8 weeks
|
8 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Expression Profile of Peripheral Blood Mononuclear Cells
大体时间:8 weeks
|
8 weeks
|
|
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Pain Assessment
大体时间:8 weeks
|
VAS Pain Scale
|
8 weeks
|
|
Endothelial Function
大体时间:8 weeks
|
EndoPat
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (实际的)
2016年7月1日
研究注册日期
首次提交
2016年2月3日
首先提交符合 QC 标准的
2016年2月9日
首次发布 (估计)
2016年2月10日
研究记录更新
最后更新发布 (估计)
2016年8月1日
上次提交的符合 QC 标准的更新
2016年7月28日
最后验证
2016年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.