Recruiting
Phase 2
The Effect of CBD on Sleep Quality Following Late Evening Exercise
Condition(s) studied
Sleep Quality
Investigational drug(s) / intervention(s)
Cannabidiol or placebolate evening exercise
Cannabidiol or placebo: participants receive 2 x 200mg CBD or placebo
late evening exercise: Participants perform a late evening high-intensity interval training (HIIT) ending 1 hour prior to sleep
Study summary
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.
Eligibility
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. 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.
3. Age between 18-40 years old at the time of signing the Informed Consent Form (ICF)
4. Recreationally active (between 2-8h/wk)
5. Good health status confirmed by a sport medical screening
6. Body fat percentage below 20% (males) or 25% (females) as estimated by a Dual-energy X-ray absorptiometry (DXA) scan
7. Good sleep efficiency determined by the Pittsburgh Sleep Quality Index (PSQI, score ≤ 4)
Exclusion Criteria:
1. Self-reported sleep disturbances
2. Habitual smoking (\> 1 occasion/month)
3. Any kind of injury/incapability that is a contra-indication to perform high intensity interval training
4. 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.
5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device
6. Use of CBD related products 3 months prior to the start of the experimental trial (including CBD oil, cannabis or other substances containing cannabinoids)
7. Intake of any medication or nutritional supplement that influences sleep quality 3 months prior to the start of the experimental trial
8. Shift workers or extreme morning and evening chronotypes (scores between 16-30 or 70-86 on the Morningness-Eveningness Questionnaire (MEQ))
Primary outcome measure(s)
- sleep efficiency — Nightly assessment on three specific study nights, separated by 7-day intervals
the primary outcome of the current study is the parameter sleep efficiency (SE = time asleep (min) / time in bed (min)) measured by PSG
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Bakala Athletic Performance Facility |
Leuven |
Vlaams-Brabant |
Recruiting |
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