Trial Outcomes & Findings for Influence of Edible Marijuana on Endurance Exercise Performance (NCT NCT05192239)
NCT ID: NCT05192239
Last Updated: 2024-04-22
Results Overview
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.
COMPLETED
EARLY_PHASE1
17 participants
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.
2024-04-22
Participant Flow
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).
Participant milestones
| Measure |
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
|
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
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|---|---|---|
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Overall Study
STARTED
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5
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5
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Overall Study
COMPLETED
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5
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5
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Randomized Crossover Study
n=9 Participants
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.
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|---|---|
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Age, Continuous
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25 years
STANDARD_DEVIATION 3 • n=9 Participants
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Sex: Female, Male
Female
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1 Participants
n=9 Participants
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Sex: Female, Male
Male
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8 Participants
n=9 Participants
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Height
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167.3 cm
STANDARD_DEVIATION 25.5 • n=9 Participants
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Body Mass
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75.97 kg
STANDARD_DEVIATION 13.30 • n=9 Participants
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Lean Mass
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57.98 kg
STANDARD_DEVIATION 9.79 • n=9 Participants
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Body Fat
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20.12 % of body fat
STANDARD_DEVIATION 3.05 • n=9 Participants
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VO2 peak
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56.5 ml/kg/min
STANDARD_DEVIATION 11.7 • n=9 Participants
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PRIMARY outcome
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.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.
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
|
|---|---|---|
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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
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0.9699 mmol/L
Standard Deviation 0.3711208
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1.1437 mmol/L
Standard Deviation 0.358376
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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
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1.26345 mmol/L
Standard Deviation 0.47071
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1.3618 mmol/L
Standard Deviation 0.343596
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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
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1.6075 mmol/L
Standard Deviation 0.9670983
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1.3558333 mmol/L
Standard Deviation 0.7374943
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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
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2.5896 mmol/L
Standard Deviation 2.254174
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2.4418 mmol/L
Standard Deviation 2.2780711
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PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
|
|---|---|---|
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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
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66 bpm
Standard Deviation 16
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63 bpm
Standard Deviation 13
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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
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95 bpm
Standard Deviation 14
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97 bpm
Standard Deviation 15
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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
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108 bpm
Standard Deviation 18
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113 bpm
Standard Deviation 20
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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
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130 bpm
Standard Deviation 26
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135 bpm
Standard Deviation 27
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PRIMARY outcome
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).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.
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
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|---|---|---|
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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
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6 units on a scale
Standard Deviation 0
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6 units on a scale
Standard Deviation 0
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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
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8 units on a scale
Standard Deviation 1
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8 units on a scale
Standard Deviation 1
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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
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11 units on a scale
Standard Deviation 1
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10 units on a scale
Standard Deviation 1
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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
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12 units on a scale
Standard Deviation 1
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12 units on a scale
Standard Deviation 1
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PRIMARY outcome
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).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.
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
|
|---|---|---|
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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
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1.26404 L/min
Standard Deviation 0.31999
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1.24939816 L/min
Standard Deviation 0.15584784
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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
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1.66361 L/min
Standard Deviation 0.18041
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1.664867728 L/min
Standard Deviation 0.138618921
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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
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2.11388 L/min
Standard Deviation 0.15106
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2.126941406 L/min
Standard Deviation 0.133666814
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PRIMARY outcome
Timeframe: Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsMean maximal power will be measured over 20 minutes following ingestion of placebo or active formula
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
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|---|---|---|
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Comparison of Maximal Mean Power Output to Placebo
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422 watts
Standard Deviation 92
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454 watts
Standard Deviation 77
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo
n=9 Participants
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
|
10 mg THC
n=9 Participants
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
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|---|---|---|
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Comparison of Time to Exhaustion to Placebo
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43 seconds
Standard Deviation 33
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43 seconds
Standard Deviation 32
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Adverse Events
Placebo
10 mg THC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christopher Bell, Associate Professor
Colorado State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place