Cannabinoid Supplementation on Vascular and Cognitive Function
2019年10月21日 更新者：Phil Ainslie、University of British Columbia
The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.
Cannabidiol (CBD) is a bioactive cannabinoid compound in marijuana (cannabis sativa), but unlike Δ9 tetrahydrocannabinol (THC), lacks the psychoactivity effect of THC.
Available evidence suggests that there are marked therapeutic CBD effects for diverse disease processes including inflammation, cancers, psychosis, and epileptic seizures.
The purpose of this study, in both younger and older healthy humans, is to improve our understanding of how CBD might control and regulate blood vessel health as well as cognitive and exercise performance.
研究概览
研究类型
介入性
注册 (预期的)
24
阶段
- 第一阶段早期
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
-
-
Ontario
-
Kelowna、Ontario、加拿大、V1V 1V7
- University of British Columbia
-
-
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
18年 至 75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:
- non-smoking
- non-obese
- between the ages of 18-30 & 60-75 years
- have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.
Exclusion Criteria:
- are obese
- are taking prescription drugs or over-the-counter supplements that influence cardiovascular or nitric oxide metabolism
- have a history of smoking
- have history of cardiovascular, respiratory (including asthma) or neurological disease
- have known intolerance to ginseng or ginkgo herbals
- have kidney, gastrointestinal or liver disease
- have epilepsy
- have diabetes
- are pregnant or breast feeding
- do not speak English as first language
- a student in the University of British Columbia (UBC) Okanagan Centre for Heart, Lung and Vascular Health
- medical or recreational use of cannabis
- clinically diagnosed anxiety or depression
- history of opioid use
- unwilling or unable to execute the informed consent documentation
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
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Sugar pill that will have no effect.
|
Subjects will be administered in a double-blinded, randomized and cross-over design
|
|
有源比较器：Cannabidiol and herbal capsules (1 dose)
Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
|
Subjects will be administered in a double-blinded, randomized and cross-over design
|
|
有源比较器：Cannabidiol (1 dose)
Only cannabidiol supplement.
|
Subjects will be administered in a double-blinded, randomized and cross-over design
|
|
有源比较器：Cannabidiol and herbal capsules (2 dose)
Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.
|
Subjects will be administered in a double-blinded, randomized and cross-over design
|
|
有源比较器：Cannabidiol only (2 dose)
Only cannabidiol supplement.
|
Subjects will be administered in a double-blinded, randomized and cross-over design
|
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 |
|---|---|---|
|
Circulating cannabidiol and nitric oxide markers
大体时间：Through study completion, an average of 1 year
|
Measured by venous blood sampling
|
Through study completion, an average of 1 year
|
|
Vascular function
大体时间：Through study completion, an average of 1 year
|
Duplex ultrasound system
|
Through study completion, an average of 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
心率
大体时间：通过学习完成，平均1年
|
通过 3 导联心电图测量
|
通过学习完成，平均1年
|
|
Height
大体时间：Through study completion, an average of 1 year
|
Height in cm
|
Through study completion, an average of 1 year
|
|
Weight
大体时间：Through study completion, an average of 1 year
|
Weight in kg
|
Through study completion, an average of 1 year
|
|
Body mass index
大体时间：Through study completion, an average of 1 year
|
Body mass in kilograms divided by height in meters squared
|
Through study completion, an average of 1 year
|
|
Systolic blood pressure
大体时间：Through study completion, an average of 1 year
|
Measured by automated sphygmomanometer
|
Through study completion, an average of 1 year
|
|
Diastolic blood pressure
大体时间：Through study completion, an average of 1 year
|
Measured by automated sphygmomanometer
|
Through study completion, an average of 1 year
|
|
Respiration
大体时间：Through study completion, an average of 1 year
|
Measured by spirometry
|
Through study completion, an average of 1 year
|
|
Medical History Questionnaire
大体时间：Through study completion, an average of 1 year
|
Assesses inclusion/exclusion criteria and prior history of medical conditions.
|
Through study completion, an average of 1 year
|
|
Gastrointestinal Distress Questionnaire
大体时间：Through study completion, an average of 1 year
|
Measured using a 10 cm visual analogue scale
|
Through study completion, an average of 1 year
|
|
Anxiety Questionnaire
大体时间：Through study completion, an average of 1 year
|
Assessed with a visual analog scale
|
Through study completion, an average of 1 year
|
|
Cognitive performance
大体时间：Through study completion, an average of 1 year
|
Computerized battery of neuropsychological tests
|
Through study completion, an average of 1 year
|
|
Exercise performance
大体时间：Through study completion, an average of 1 year
|
Step-wise exercise test on cycle ergometer
|
Through study completion, an average of 1 year
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2018年1月1日
初级完成 (预期的)
2021年9月30日
研究完成 (预期的)
2021年10月1日
研究注册日期
首次提交
2017年9月20日
首先提交符合 QC 标准的
2017年9月22日
首次发布 (实际的)
2017年9月28日
研究记录更新
最后更新发布 (实际的)
2019年10月23日
上次提交的符合 QC 标准的更新
2019年10月21日
最后验证
2019年10月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual values will be reported in figures if applicable.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.