Clinical trial NCT05192239: Influence of Edible Marijuana on Endurance Exercise Performance
Official title: Influence of Edible Marijuana on Endurance Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endurance Exercise
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
Primary purpose: BASIC_SCIENCE

Brief summary: Lots of people, including athletes and people who like to exercise regularly, enjoy marijuana. Some people believe marijuana might improve their ability to exercise. There are no recent, up-to-date scientific studies to suggest that this belief is right or wrong. The goal of this study is to determine the influence of marijuana on exercise performance.

Detailed description: The purpose of the proposed project is to provide athletes and the scientific community with data pertaining to the acute influence of edible marijuana on exercise performance, and the physiological responses to standardized exercise. Specifically, the investigators wish to determine: 1. The influence of edible marijuana on cardio-respiratory and metabolic responses to standardized cycle ergometer exercise. 2. The influence of edible marijuana on endurance exercise (time-trial) performance.

The investigators wish to determine if edible marijuana, ingested prior to exercise, is ergogenic (improves performance) or ergolytic (decreases performance).

The investigators hypothesize that edible marijuana will be ergolytic.

Eligibility criteria: Inclusion Criteria:

* Between the age of 21 and 40.
* Weigh more than 110 pounds
* Habitual user of cannabis; average use of THC minimum of once per month during the previous year
* Prior use of cannabis product containing at least 10 mg of THC with no adverse reaction
* Habitual exerciser: exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during the previous year.

Exclusion Criteria:

* Identification of a contra-indication to exercise during a 12-lead exercise stress test.
* Pregnant or trying to become pregnant. Breastfeeding.
* Recipient of treatment for psychotic or bipolar disorder during the previous 2 years
* Recipient of treatment for Schizophrenia during the previous 2 years
* Planned surgery scheduled within 2-weeks of study participation

Primary outcomes:
measure: Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
timeFrame: Blood was collected at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts), and 24 minutes (150 watts) for analysis of blood lactate.
measure: Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
timeFrame: Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts)
measure: Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
timeFrame: RPE was reported and averaged for each intensity stage at timepoints 0 minutes- 4 minutes (0 watts), 8 minutes-12 minutes (50 watts), 16 minutes-20 minutes (100 watts), and 24 minutes (150 watts).
measure: Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
timeFrame: Expired gasses were measured and averaged during three time points, 5-8 minutes (50 Watts), 13-16 minutes (150 Watts), and 21-24 minutes (150 Watts).
measure: Comparison of Maximal Mean Power Output to Placebo
timeFrame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
measure: Comparison of Time to Exhaustion to Placebo
timeFrame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University, Dept. of Health and Exercise Science
state: Colorado
Study officials:
References: