RecruitingPhase 2NCT07570472

The Effect of CBD on Sleep Quality Following Late Evening Exercise

Sponsor

KU Leuven

Enrollment

20 participants

Start Date

Mar 19, 2026

Study Type

INTERVENTIONAL

Conditions

Sleep Quality

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

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria7

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)

Exclusion Criteria8

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))