The Effect of CBD on Sleep Quality Following Late Evening Exercise
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The trial is a double-blind, placebo-controlled crossover design. In a randomized order, 20 participants undergo one control and two experimental sessions separated by a 1-week wash out period. During the no exercise/rest session, participants' sleep is monitored via polysomnography following a rest day. During the training sessions participants' sleep is monitored following a high intensity interval training (HIIT) in the late evening (finishing 1h prior to bedtime). During these sessions participants receive 2x 200mg CBD or placebo in a randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Use of highly effective methods of birth control during the entire trial and for up to 4 months after the last dose of CBD; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- •Age between 18-40 years old at the time of signing the Informed Consent Form (ICF)
- •Recreationally active (between 2-8h/wk)
- •Good health status confirmed by a sport medical screening
- •Body fat percentage below 20% (males) or 25% (females) as estimated by a Dual-energy X-ray absorptiometry (DXA) scan
- •Good sleep efficiency determined by the Pittsburgh Sleep Quality Index (PSQI, score ≤ 4)
排除标准
- •Self-reported sleep disturbances
- •Habitual smoking (> 1 occasion/month)
- •Any kind of injury/incapability that is a contra-indication to perform high intensity interval training
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- •Use of CBD related products 3 months prior to the start of the experimental trial (including CBD oil, cannabis or other substances containing cannabinoids)
- •Intake of any medication or nutritional supplement that influences sleep quality 3 months prior to the start of the experimental trial
- •Shift workers or extreme morning and evening chronotypes (scores between 16-30 or 70-86 on the Morningness-Eveningness Questionnaire (MEQ))
研究组 & 干预措施
Exercise session 1
Participants perform a late evening exercise and receive placebo/CBD supplements
干预措施: Cannabidiol or placebo (Drug)
Exercise session 1
Participants perform a late evening exercise and receive placebo/CBD supplements
干预措施: late evening exercise (Behavioral)
Exercise session 2
Participants perform a late evening exercise and receive placebo/CBD supplements
干预措施: Cannabidiol or placebo (Drug)
Exercise session 2
Participants perform a late evening exercise and receive placebo/CBD supplements
干预措施: late evening exercise (Behavioral)
No exercise / rest session
Participants do not perform a late evening exercise and receive placebo/CBD supplements
干预措施: Cannabidiol or placebo (Drug)