- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05192239
Influence of Edible Marijuana on Endurance Exercise Performance
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Colorado
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Fort Collins, Colorado, United States, 80523-1582
- Colorado State University, Dept. of Health and Exercise Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy.
One time, two gummies will be ingested prior to an exercise bout.
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Commercially available non-THC fruit snack
Other Names:
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Active Comparator: 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.
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5 milligrams of THC in gummy form
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
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.
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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.
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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.
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)
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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).
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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.
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).
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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.
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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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Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
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).
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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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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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Comparison of Maximal Mean Power Output to Placebo
Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
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Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula
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Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
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Comparison of Time to Exhaustion to Placebo
Time Frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
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Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise
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Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2827
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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