Endurance Exercise
Conditions
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.
Interventions
DRUGTHC 5
5 milligrams of THC in gummy form
DRUGPlacebo
Commercially available non-THC fruit snack
Sponsors
Christopher Bell
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Coded envelope.
Intervention model description
Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 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. | 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. |
| Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts) | 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). |
| Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 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). | 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. |
| Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 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). | 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. |
| Comparison of Maximal Mean Power Output to Placebo | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions | Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula |
| Comparison of Time to Exhaustion to Placebo | Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. | Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Randomized Crossover Study | — |
|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 3 | — |
| Body Fat | 20.12 % of body fat STANDARD_DEVIATION 3.05 | — |
| Body Mass | 75.97 kg STANDARD_DEVIATION 13.3 | — |
| Height | 167.3 cm STANDARD_DEVIATION 25.5 | — |
| Lean Mass | 57.98 kg STANDARD_DEVIATION 9.79 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
| VO2 peak | 56.5 ml/kg/min STANDARD_DEVIATION 11.7 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 minutes - 0 watts | 0.9699 mmol/L | Standard Deviation 0.3711208 |
| Placebo | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 minutes - 50 watts | 1.26345 mmol/L | Standard Deviation 0.47071 |
| Placebo | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 minutes - 100 watts | 1.6075 mmol/L | Standard Deviation 0.9670983 |
| Placebo | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 2.5896 mmol/L | Standard Deviation 2.254174 |
| 10 mg THC | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 2.4418 mmol/L | Standard Deviation 2.2780711 |
| 10 mg THC | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 minutes - 0 watts | 1.1437 mmol/L | Standard Deviation 0.358376 |
| 10 mg THC | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 minutes - 100 watts | 1.3558333 mmol/L | Standard Deviation 0.7374943 |
| 10 mg THC | Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 minutes - 50 watts | 1.3618 mmol/L | Standard Deviation 0.343596 |
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).
Time frame: Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 minutes - 0 watts | 66 bpm | Standard Deviation 16 |
| Placebo | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 minutes - 50 watts | 95 bpm | Standard Deviation 14 |
| Placebo | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 minutes - 100 watts | 108 bpm | Standard Deviation 18 |
| Placebo | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 130 bpm | Standard Deviation 26 |
| 10 mg THC | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 135 bpm | Standard Deviation 27 |
| 10 mg THC | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 minutes - 0 watts | 63 bpm | Standard Deviation 13 |
| 10 mg THC | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 minutes - 100 watts | 113 bpm | Standard Deviation 20 |
| 10 mg THC | Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 minutes - 50 watts | 97 bpm | Standard Deviation 15 |
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 5-8 minutes- 50 watts | 1.26404 L/min | Standard Deviation 0.31999 |
| Placebo | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 13-16 minutes-100 watts | 1.66361 L/min | Standard Deviation 0.18041 |
| Placebo | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 21-24 minutes- 150 watts | 2.11388 L/min | Standard Deviation 0.15106 |
| 10 mg THC | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 5-8 minutes- 50 watts | 1.24939816 L/min | Standard Deviation 0.15584784 |
| 10 mg THC | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 13-16 minutes-100 watts | 1.664867728 L/min | Standard Deviation 0.138618921 |
| 10 mg THC | Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 21-24 minutes- 150 watts | 2.126941406 L/min | Standard Deviation 0.133666814 |
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
Time frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Comparison of Maximal Mean Power Output to Placebo | 422 watts | Standard Deviation 92 |
| 10 mg THC | Comparison of Maximal Mean Power Output to Placebo | 454 watts | Standard Deviation 77 |
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 and 4 minutes - 0 watts | 6 units on a scale | Standard Deviation 0 |
| Placebo | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 and 12 minutes - 50 watts | 8 units on a scale | Standard Deviation 1 |
| Placebo | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 and 20 minutes - 100 watts | 11 units on a scale | Standard Deviation 1 |
| Placebo | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 12 units on a scale | Standard Deviation 1 |
| 10 mg THC | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 24 minutes - 150 watts | 12 units on a scale | Standard Deviation 1 |
| 10 mg THC | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 0 and 4 minutes - 0 watts | 6 units on a scale | Standard Deviation 0 |
| 10 mg THC | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 16 and 20 minutes - 100 watts | 10 units on a scale | Standard Deviation 1 |
| 10 mg THC | Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. | 8 and 12 minutes - 50 watts | 8 units on a scale | Standard Deviation 1 |
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
Time frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Comparison of Time to Exhaustion to Placebo | 43 seconds | Standard Deviation 33 |
| 10 mg THC | Comparison of Time to Exhaustion to Placebo | 43 seconds | Standard Deviation 32 |