CANNABIDIOL for Healthy volunteers

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n- Use of highly effective methods of birth control; 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.\n- Age between 18-40 years old at the time of signing the Informed Consent Form (ICF)\n- Recreationally active (between 2-8h/wk)\n- Good health status confirmed by a sport medical screening\n- Body fat percentage below 20% (males) or 25% (females) as estimated by a Dual-energy X-ray absorptiometry (DXA) scan\n- Good sleep efficiency determined by the Pittsburgh Sleep Quality Index (PSQI, score ≤ 4)"}

Exclusion criteria

• {"criterion_text":"- Self-reported sleep disturbances\n- Habitual smoking (> 1 occasion/month)\n- Any kind of injury/incapability that is a contra-indication to perform high-intensity interval training\n- 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\n- Participation in another interventional Trial with an investigational medicinal product (IMP) or device\n- Use of CBD related products 3 months prior to the start of the experimental trial (including CBD oil, cannabis or other substances containing cannabinoids)\n- Intake of any medication or nutritional supplement that influences sleep quality 3 months prior to the start of the experimental trial\n- Shift workers or extreme morning and evening chronotypes (scores between 16-30 or 70-86 on the Morningness-Eveningness Questionnaire (MEQ))"}

Primary endpoints

• {"endpoint_text":"- Changes in sleep efficiency between different sessions","definition_or_measurement_approach":"Sleep efficiency (SE = time asleep (min) / time in bed (min)); change in SE between different sessions."}

Secondary endpoints

• {"endpoint_text":"- Changes in other sleep indices between different sessions\n- Changes in perceived sleep quality between different sessions\n- Changes in circulating hormones involved in sleep and stress between different sessions\n- Changes in plasma catecholamines and serotonin between different sessions\n- Changes urinary catecholamine and serotonin excretion between different sessions","definition_or_measurement_approach":"Other sleep indices include sleep period time (SPT), wake after sleep onset (WASO), total sleep time (TST), sleep onset latency (SOL), sleep maintenance efficiency (SME), time in sleep stages (N1, N2, N3, REM, NREM), slow waves, sleep spindles. Perceived sleep quality assessed via questionnaires. Circulating hormones include growth hormone, melatonin, cortisol. Plasma and urinary catecholamines include adrenaline, noradrenaline, dopamine; serotonin measured in plasma and urine. Comparisons are between different sessions."}

Belgium

Earliest CTIS Part Ii Submission Date

08-12-2025

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

44

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"Austria","full_name":"Hubertus-Apotheke e.U. Mag.Pharm.Dr.A.Dominik Schantl","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}