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A Study of Cannabidiol for Sleep Quality After Evening Exercise in Healthy People

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at healthy individuals who exercise regularly. The study will use Cannabidiol, which is a substance derived from the cannabis plant, given in hard capsule form. Another product called Softisan 378, which is a non-oxidizing fat base, will also be used in the study. Both products are taken by mouth.

The purpose of this study is to investigate the effect of Cannabidiol on sleep efficiency following late evening exercise. Sleep efficiency is a measure that compares the time spent actually sleeping to the total time spent in bed. The study will examine whether taking Cannabidiol affects how well people sleep after exercising late in the evening. The study will also look at other aspects of sleep quality, how people feel about their sleep, and measure certain hormones and chemical substances in the blood and urine that are related to sleep and stress.

During the study, participants will take part in different sessions where they will receive either Cannabidiol or Softisan 378. The maximum daily amount of Cannabidiol that can be given is 400 milligrams, while the maximum daily amount of Softisan 378 is 1200 milligrams. The study will measure changes in sleep patterns between the different sessions and collect blood and urine samples to analyze various substances that affect sleep. Participants will be healthy adults between 18 and 40 years old who exercise regularly and have good sleep quality to begin with.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and health assessment

    Your health status will be confirmed through a sports medical screening to ensure you are in good health.

    A Dual-energy X-ray absorptiometry (DXA) scan will be performed to measure your body composition. This is a special type of scan that uses low-dose X-rays to determine your body fat percentage.

    Your sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which is a questionnaire that evaluates your sleep patterns and quality.

  2. Step 2

    Study sessions with treatment administration

    You will participate in multiple sessions during the study. Each session will involve different treatments to compare their effects.

    During some sessions, you will receive cannabidiol (CBD) in the form of a hard capsule taken by mouth.

    During other sessions, you will receive Softisan 378, which is a placebo substance, also in the form of a hard capsule taken by mouth.

    The specific dosage, frequency, and duration of administration have not been provided in the study documentation.

  3. Step 3

    Late evening exercise protocol

    You will perform exercise sessions in the late evening as part of the study protocol.

    The exercise will be conducted to evaluate how it affects your sleep, and how the treatment influences sleep quality after evening physical activity.

  4. Step 4

    Sleep monitoring and measurements

    Your sleep will be monitored throughout the night following the exercise session.

    Measurements will include sleep efficiency, which is calculated as the time you spend actually sleeping divided by the total time you spend in bed.

    Other sleep-related measurements will be recorded to assess various aspects of your sleep quality.

  5. Step 5

    Sleep quality assessment

    You will be asked to report your own perception of how well you slept during each session.

    This subjective assessment will be compared across the different treatment sessions.

  6. Step 6

    Blood sample collection

    Blood samples will be collected to measure hormones related to sleep and stress in your bloodstream.

    The samples will also be analyzed for catecholamines and serotonin. Catecholamines are hormones that your body releases in response to stress, while serotonin is a chemical that affects mood and sleep.

    These measurements will help determine how the treatment affects your body's chemical responses.

  7. Step 7

    Urine sample collection

    Urine samples will be collected to measure the excretion of catecholamines and serotonin.

    This provides additional information about how your body processes these chemicals during the study period.

  8. Step 8

    Comparison of results across sessions

    The results from all your sessions will be compared to determine the effect of CBD on your sleep efficiency after late evening exercise.

    Changes in sleep patterns, perceived sleep quality, hormone levels, and chemical markers will be analyzed across the different treatment conditions.

Who can join the trial?

7 criteria

  • You must provide written informed consent, which means you agree in writing to take part in the study before any tests or procedures begin
  • You must use highly effective birth control methods, which are ways to prevent pregnancy that work more than 99% of the time when used correctly. These include implants (small devices placed under the skin), injections (shots given regularly), combined birth control pills, some IUDs (devices placed inside the uterus), not having sexual intercourse at all during the study, or having a partner who has had a vasectomy (a permanent birth control procedure for men)
  • You must be between 18 and 40 years old when you sign the consent form
  • You must be recreationally active, which means you exercise regularly between 2 and 8 hours per week
  • You must be in good health, which will be confirmed by a sports medical screening
  • You must have a body fat percentage below 20% if you are male or below 25% if you are female. This will be measured using a DXA scan, which is a special type of x-ray that measures body composition
  • You must have good sleep efficiency, which means you sleep well. This will be determined using the Pittsburgh Sleep Quality Index, a questionnaire that measures sleep quality, and your score must be 4 or lower

Who cannot join the trial?

10 criteria

  • You cannot participate if you have any medical conditions, which means any health problems or diseases, as this study is only for healthy people
  • You cannot participate if you are taking any regular medications or treatments that might affect sleep or how your body processes the study substance
  • You cannot participate if you have sleep disorders, which are conditions that affect your ability to sleep well regularly, such as trouble falling asleep or staying asleep
  • You cannot participate if you use CBD products or cannabis, which are substances that come from the cannabis plant
  • You cannot participate if you are pregnant, which means carrying a baby, or breastfeeding, which means feeding a baby with milk from your breast
  • You cannot participate if you have allergies to CBD or any ingredients in the study product, which means your body has a bad reaction to these substances
  • You cannot participate if you work night shifts or have an irregular sleep schedule, as this could affect the study results
  • You cannot participate if you have recently traveled across time zones, which are different areas of the world with different times, as this can affect your sleep patterns
  • You cannot participate if you have problems with alcohol or drug use, which means using these substances in a way that could be harmful
  • You cannot participate if you have mental health conditions such as anxiety or depression that are not well controlled
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Investigated drugs

CBD is a natural compound found in cannabis plants. In this trial, it is being studied to see if it can help improve sleep quality after exercising late in the evening. The researchers want to find out if CBD can help people fall asleep more easily and sleep better when they work out close to bedtime.

What is already known about the treatment

CBD – CBD, also known as cannabidiol, is a natural compound derived from the cannabis plant that is typically administered orally in forms such as oils, capsules, or edibles. It is currently being studied in clinical research to understand its potential effects on various health conditions, including sleep quality, anxiety, and pain management, though its regulatory status varies by country. In this particular study, CBD is being investigated for its ability to improve sleep efficiency in healthy individuals after late evening exercise, which involves measuring how well a person sleeps relative to the time spent in bed. CBD works by interacting with the body's endocannabinoid system, specifically binding to receptors in the brain and nervous system that help regulate functions like mood, pain sensation, and sleep-wake cycles, without producing the psychoactive effects associated with THC.

Investigated diseases

Healthy Individuals – This study involves participants who do not have any diagnosed medical conditions or diseases. Healthy individuals are selected as subjects to establish baseline data and understand normal physiological responses. In this particular research, the focus is on examining sleep patterns and efficiency in people without health problems. The study investigates how certain interventions affect sleep quality in individuals with normal health status. These participants serve as a reference group to understand typical sleep mechanisms. The research examines various sleep-related measurements in people who are free from medical disorders.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518609-17-00Estimated enrolment20 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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