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临床试验/NCT03295903
NCT03295903Unknown1 期

The Effects of Cannabinoids on Vascular and Cognitive Function in Young and Old Healthy Adults.

University of British Columbia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
24
试验地点
1
主要终点
Circulating cannabidiol and nitric oxide markers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •non-smoking
  • •non-obese
  • •between the ages of 18-30 & 60-75 years
  • •have no history of cardiopulmonary, liver, gastrointestinal, kidney or cerebrovascular disease.

排除标准

  • •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

研究组 & 干预措施

Placebo

Placebo Comparator

Sugar pill that will have no effect.

干预措施: Cannabidiol supplement (Dietary Supplement)

Cannabidiol and herbal capsules (1 dose)

Active Comparator

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

干预措施: Cannabidiol supplement (Dietary Supplement)

Cannabidiol (1 dose)

Active Comparator

Only cannabidiol supplement.

干预措施: Cannabidiol supplement (Dietary Supplement)

Cannabidiol and herbal capsules (2 dose)

Active Comparator

Cannabidiol supplement with added ginseng, ginkgo biloba, and organic hemp oil.

干预措施: Cannabidiol supplement (Dietary Supplement)

Cannabidiol only (2 dose)

Active Comparator

Only cannabidiol supplement.

干预措施: Cannabidiol supplement (Dietary Supplement)

结局指标

主要结局

Circulating cannabidiol and nitric oxide markers

时间窗: Through study completion, an average of 1 year

Measured by venous blood sampling

Vascular function

时间窗: Through study completion, an average of 1 year

Duplex ultrasound system

次要结局

  • Height(Through study completion, an average of 1 year)
  • Weight(Through study completion, an average of 1 year)
  • Exercise performance(Through study completion, an average of 1 year)
  • Anxiety Questionnaire(Through study completion, an average of 1 year)
  • Body mass index(Through study completion, an average of 1 year)
  • Systolic blood pressure(Through study completion, an average of 1 year)
  • Diastolic blood pressure(Through study completion, an average of 1 year)
  • Heart rate(Through study completion, an average of 1 year)
  • Respiration(Through study completion, an average of 1 year)
  • Medical History Questionnaire(Through study completion, an average of 1 year)
  • Cognitive performance(Through study completion, an average of 1 year)
  • Gastrointestinal Distress Questionnaire(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phil Ainslie

Professor

University of British Columbia

研究点 (1)

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