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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. |
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| 10 mg THC | Active Comparator | Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC 5 | Drug | 5 milligrams of THC in gummy form |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula. | 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. |
| Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.Heart rate will be collected during standard graded exercise following ingestion of placebo or active formula (10mg THC in the form of two 5mg gummies). | Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts) |
| Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.During standard exercise, participants will be asked to report Rating of Perceived Exertion (RPE) on a scale from 6-20 (6 is no exertion and 20 is maximal exertion) during a graded standard exercise test following ingestion of placebo or active formula. | 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). |
| Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsVO2 will be collected during graded standard exercise following ingestion of placebo or active formula. Expired gasses were measured and averaged during three time points, 5-8 minutes, 13-16 minutes, and 21-24 minutes. Gasses were not collected or recorded outside of those timeframes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University, Dept. of Health and Exercise Science | Fort Collins | Colorado | 80523-1582 | United States |
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| Label | URL |
|---|---|
| Link to Published Manuscript | View source |
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Seventeen adults were assessed for eligibility and enrolled in the study. Two adults declined invitations to schedule post-screening study visits, two were excluded from participation on account of use of contraindicated medications, and three were discontinued during the habituation visits as they were unable to sustain the required work rate. This all occurred prior to treatment assignments (randomization).
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| ID | Title | Description |
|---|---|---|
| FG000 | THC Gummy First, Then Placebo Gummy | Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. THC 5: 5 milligrams of THC in gummy form 4-day minimum washout period Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. Placebo: Commercially available non-THC fruit snack |
| FG001 | Placebo Gummy First, Then THC Gummy | Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. Placebo: Commercially available non-THC fruit snack 4-day minimum washout period Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. THC 5: 5 milligrams of THC in gummy form |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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10 participants completed both measures (Placebo and THC). 9 participants were analyzed. 1 participant was excluded from analyses due to failure to abstain.
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Crossover Study | Participants first received either a Placebo gummy (commercially available non-THC fruit snack) or 2 5mg THC gummies prior to an exercise bout. Visits were separated by a 4-day washout period. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula. | Posted | Mean | Standard Deviation | mmol/L | 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. |
|
Each study participant was monitored for Adverse Events for 30 minutes post-invention, with a 4-day washout period in between interventions. During the 24 hours post-intervention, study participants were instructed to email study staff to report new or recurring events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. Placebo: Commercially available non-THC fruit snack |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Bell, Associate Professor | Colorado State University | (970) 491-7522 | christopher.bell@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 31, 2022 | Jun 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2022 | Jun 27, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2021 | Jun 27, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C117173 | THC 5 |
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Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
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Coded envelope.
| Placebo | Drug | Commercially available non-THC fruit snack |
|
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| 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). |
| Comparison of Maximal Mean Power Output to Placebo | Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions |
| Comparison of Time to Exhaustion to Placebo | Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
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| Body Mass | Mean | Standard Deviation | kg |
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| Lean Mass | Mean | Standard Deviation | kg |
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| Body Fat | Mean | Standard Deviation | % of body fat |
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| VO2 peak | Peak oxygen uptake | Mean | Standard Deviation | L/min |
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| VO2 peak | Peak oxygen uptake. | Mean | Standard Deviation | ml/kg/min |
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Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. THC 5: 5 milligrams of THC in gummy form |
|
|
| Primary | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.Heart rate will be collected during standard graded exercise following ingestion of placebo or active formula (10mg THC in the form of two 5mg gummies). | Posted | Mean | Standard Deviation | bpm | Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts) |
|
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|
| Primary | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.During standard exercise, participants will be asked to report Rating of Perceived Exertion (RPE) on a scale from 6-20 (6 is no exertion and 20 is maximal exertion) during a graded standard exercise test following ingestion of placebo or active formula. | Posted | Mean | Standard Deviation | units on a scale | 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). |
|
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| Primary | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsVO2 will be collected during graded standard exercise following ingestion of placebo or active formula. Expired gasses were measured and averaged during three time points, 5-8 minutes, 13-16 minutes, and 21-24 minutes. Gasses were not collected or recorded outside of those timeframes. | Posted | Mean | Standard Deviation | L/min | 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). |
|
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| Primary | Comparison of Maximal Mean Power Output to Placebo | Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula | Posted | Mean | Standard Deviation | watts | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions |
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| Primary | Comparison of Time to Exhaustion to Placebo | Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise | Posted | Mean | Standard Deviation | seconds | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 10 mg THC | Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. THC 5: 5 milligrams of THC in gummy form | 0 | 10 | 0 | 10 | 0 | 10 |
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| 16 minutes - 100 watts |
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| 24 minutes - 150 watts |
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| 16 and 20 minutes - 100 watts |
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| 24 minutes - 150 watts |
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| 21-24 minutes- 150 watts |
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