HealthyNCT06364254
Effects of CBD on 2 Mile Run Time Trial Performance
A study testing Cannabidiol Capsules in people with Healthy, run by University of Northern Colorado at 1 site in United States.
Trial summary
Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cannabidiol Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Running at least 2 miles 2 times per week.
Who cannot join
- Current diagnosis of a chronic disease or serious mental health disorder.
- Current or use of cannabis or cannabis products within the past 4 weeks
- Currently in perimenopause or menopause, transgender female not undergoing hormone treatment (estrogen)
- Having any underlying health concerns or have any current injuries that can be worsened with exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Northern Colorado
Greeley, Colorado, 80639
About this study
Official title: The Effects of CBD on 2 Mile Run Time Trial Performance, GI Distress, and Anxiety in Moderately Active Females
Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female.
Read the detailed description
This study will recruit moderately active, healthy individuals (N=30) who identify as female between the ages of 18-40 years who have some running experience and are running at least 2 miles, 2 times per week. This will be a cross over study, so each participant will be their own control, receiving either the placebo and CBD on two separate occasions. The females recruited will report to the Exercise Physiology lab in Gunter Hall on the University of Northern Colorado's campus for testing a total of two times.
The first visit will include initial paperwork such as the informed consent, physical activity readiness questionnaire (PARQ), Menstrual Cycle Questionnaire and a screening to determine current activity levels, uses CBD, THC and any other legal drugs/medications. This first interaction allows study staff to ensure that qualify to take part in the study.
After informed consent is obtained, the participant will be given either the placebo or CBD capsule with a controlled higher fat food (88 Acres protein bar) 2 hours before the testing protocol along. Once the CBD capsule or placebo is taken, participants will complete caffeine consumption, exercise and running questionnaires which will be administered on a tablet with study staff after 1.5 hours or waiting.
During the first visit, individuals will stay for a standardized period (2 hours) before doing a urine analysis to determine hydration status and taking v lactate, and heart rate variability. Current anxiety symptoms will also be evaluated
Once baseline measurements obtained, individuals will then be instructed to run 2 miles a treadmill as fast as possible. Lactate will be monitored three times during the test (.50 mile mark, halfway point (1 mile) and just before finishing the time trial run at the 1.98 mile mark). All participants will be taken through a 30-minute cool down period walking 2.5 mph on the treadmill while having lactate measured every 5, 10, 15, and 30 minutes post finishing. Finish time, GI distress questionnaire, and overall feelings will be recorded post finish of the 2 mile time trial.
Participants will be given a 25-30 day time between visits 1 and 2 to ensure exercise during the same menstrual cycle phase (hormone cycle) for those that are cycling. During the second and final visit, participants will undergo the same procedure, however, will be given the opposite oral administration from the first visit (either placebo or CBD).
- Conditions
- Healthy
- Being tested
- Cannabidiol Capsules
- Keywords
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol CapsulesDietary supplement
300 mg of cannabidiol administered 2 hours before 2 mile run
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Cannabidiol capsules 2 hours prior to 2 mile run. Receives: Dietary Supplement: Cannabidiol Capsules |
| Placebo | Placebo comparator | Placebo capsules 2 hours prior to 2 mile run. Receives: Dietary Supplement: Cannabidiol Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Time Trial Times
Time to run 2 miles on an indoor treadmill
Measured: 10-25 minutes
Difference in Anxiety Measured with the State Trait Anxiety Inventory
This questionnaire will be administered just before each run to assess the individual's current anxiety symptoms.The State-Trait Anxiety Inventory (STAI) consists of 20 items aimed at evaluating trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Not at all" to "Very much so"). Higher scores suggest elevated anxiety.
Measured: 5 minutes
Difference in Blood Lactate Concentrations
Blood lactate will be measured just before the time trial, 3 minutes after the start of the run, after 1 mile and 1.98 miles of running and after 5, 10, 15, and 30 minutes of walking recovery. Higher lactate concentrations are associated with more effort during exercise and a slower recovery from exercise.
Measured: 45 minutes
Difference in Gastrointestinal Distress
This questionnaire consists of 12 questions related to distress symptoms. Responses are absent, mild, moderate, severe. The higher the score, the more GI distress is present. This assessment will be completed after the 2 mile run.
Measured: 5 minutes
Different in Heart Rate Variability
The root mean square successive difference method will be used with the 10 second electrocardiogram reading. Higher heart rate variability is associated with better health.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Nov 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Northern Colorado
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, University of Northern Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364254
- Sponsor's protocol ID
- 2311054791
- Status last verified
- May 2024
- First submitted
- 8 Mar 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of CBD on 2 Mile Run Time Trial Performance, GI Distress, and Anxiety in Moderately Active Females
- ClinicalTrials.gov ID
- NCT06364254
- Acronym / sponsor ID
- 2311054791
- Conditions
- Healthy
- Keywords
- Cannabidiol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Northern ColoradoUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female.
Detailed description
This study will recruit moderately active, healthy individuals (N=30) who identify as female between the ages of 18-40 years who have some running experience and are running at least 2 miles, 2 times per week. This will be a cross over study, so each participant will be their own control, receiving either the placebo and CBD on two separate occasions. The females recruited will report to the Exercise Physiology lab in Gunter Hall on the University of Northern Colorado's campus for testing a total of two times.
The first visit will include initial paperwork such as the informed consent, physical activity readiness questionnaire (PARQ), Menstrual Cycle Questionnaire and a screening to determine current activity levels, uses CBD, THC and any other legal drugs/medications. This first interaction allows study staff to ensure that qualify to take part in the study.
After informed consent is obtained, the participant will be given either the placebo or CBD capsule with a controlled higher fat food (88 Acres protein bar) 2 hours before the testing protocol along. Once the CBD capsule or placebo is taken, participants will complete caffeine consumption, exercise and running questionnaires which will be administered on a tablet with study staff after 1.5 hours or waiting.
During the first visit, individuals will stay for a standardized period (2 hours) before doing a urine analysis to determine hydration status and taking v lactate, and heart rate variability. Current anxiety symptoms will also be evaluated
Once baseline measurements obtained, individuals will then be instructed to run 2 miles a treadmill as fast as possible. Lactate will be monitored three times during the test (.50 mile mark, halfway point (1 mile) and just before finishing the time trial run at the 1.98 mile mark). All participants will be taken through a 30-minute cool down period walking 2.5 mph on the treadmill while having lactate measured every 5, 10, 15, and 30 minutes post finishing. Finish time, GI distress questionnaire, and overall feelings will be recorded post finish of the 2 mile time trial.
Participants will be given a 25-30 day time between visits 1 and 2 to ensure exercise during the same menstrual cycle phase (hormone cycle) for those that are cycling. During the second and final visit, participants will undergo the same procedure, however, will be given the opposite oral administration from the first visit (either placebo or CBD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Dietary Supplement: Cannabidiol CapsulesCannabidiol capsules 2 hours prior to 2 mile run. |
| Placebo | Placebo comparator | Dietary Supplement: Cannabidiol CapsulesPlacebo capsules 2 hours prior to 2 mile run. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Running at least 2 miles 2 times per week.
Key exclusion criteria (4 listed)
- Current diagnosis of a chronic disease or serious mental health disorder.
- Current or use of cannabis or cannabis products within the past 4 weeks
- Currently in perimenopause or menopause, transgender female not undergoing hormone treatment (estrogen)
- Having any underlying health concerns or have any current injuries that can be worsened with exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol Capsules300 mg of cannabidiol administered 2 hours before 2 mile run | Dietary supplement | Cannabidiol, Placebo |
Primary outcome
Difference in Time Trial Times
Time frame: 10-25 minutes
Time to run 2 miles on an indoor treadmill
Difference in Anxiety Measured with the State Trait Anxiety Inventory
Time frame: 5 minutes
This questionnaire will be administered just before each run to assess the individual's current anxiety symptoms.The State-Trait Anxiety Inventory (STAI) consists of 20 items aimed at evaluating trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Not at all" to "Very much so"). Higher scores suggest elevated anxiety.
Difference in Blood Lactate Concentrations
Time frame: 45 minutes
Blood lactate will be measured just before the time trial, 3 minutes after the start of the run, after 1 mile and 1.98 miles of running and after 5, 10, 15, and 30 minutes of walking recovery. Higher lactate concentrations are associated with more effort during exercise and a slower recovery from exercise.
Difference in Gastrointestinal Distress
Time frame: 5 minutes
This questionnaire consists of 12 questions related to distress symptoms. Responses are absent, mild, moderate, severe. The higher the score, the more GI distress is present. This assessment will be completed after the 2 mile run.
Different in Heart Rate Variability
Time frame: 5 minutes
The root mean square successive difference method will be used with the 10 second electrocardiogram reading. Higher heart rate variability is associated with better health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabidiol Capsules in people with Healthy, run by University of Northern Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Time Trial Times (time frame: 10-25 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.