Clinical trial NCT06364254: Effects of CBD on 2 Mile Run Time Trial Performance
Official title: The Effects of CBD on 2 Mile Run Time Trial Performance, GI Distress, and Anxiety in Moderately Active Females
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Cannabidiol
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Difference in Time Trial Times
timeFrame: 10-25 minutes
measure: Difference in Anxiety Measured with the State Trait Anxiety Inventory
timeFrame: 5 minutes
measure: Difference in Blood Lactate Concentrations
timeFrame: 45 minutes
measure: Difference in Gastrointestinal Distress
timeFrame: 5 minutes
measure: Different in Heart Rate Variability
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Greeley
country: United States
facility: University Of Northern Colorado
state: Colorado
Study officials:
References: