Effects of CBD on 2 Mile Run Time Trial Performance

NCT ID: NCT06364254

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2024-05-30

Brief 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. 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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Cannabidiol

Cannabidiol capsules 2 hours prior to 2 mile run.

Group Type: EXPERIMENTAL

Cannabidiol Capsules

Intervention Type: DIETARY_SUPPLEMENT

300 mg of cannabidiol administered 2 hours before 2 mile run

Placebo

Placebo capsules 2 hours prior to 2 mile run.

Group Type: PLACEBO_COMPARATOR

Cannabidiol Capsules

Intervention Type: DIETARY_SUPPLEMENT

300 mg of cannabidiol administered 2 hours before 2 mile run

Interventions

Cannabidiol Capsules

300 mg of cannabidiol administered 2 hours before 2 mile run

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Running at least 2 miles 2 times per week.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Northern Colorado

OTHER

Sponsor Role: lead

Responsible Party

Laura Stewart

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Of Northern Colorado

Greeley, Colorado, United States

Countries

United States

Other Identifiers

2311054791

Identifier Type: -

Identifier Source: org_study_id