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Influence of Edible Marijuana on Endurance Exercise Performance

Primary Purpose

Endurance Exercise

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

THC 5

Placebo

About this trial

This is an interventional basic science trial for Endurance Exercise

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Colorado State University, Dept. of Health and Exercise Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

10 mg THC

Arm Description

Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout.

Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout.

Outcomes

Primary Outcome Measures

Comparison of Blood Lactate Levels during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo.

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 will be collected during standard exercise graded exercise following ingestion of placebo or active formula.

Comparison of Rating of Perceived Exertion (RPE) during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo.

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.

VO2 will be collected during graded standard exercise following ingestion of placebo or active formula.

Comparison of Maximal Mean Power Output to placebo

Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula

Comparison of Time to Exhaustion to placebo

Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula

Secondary Outcome Measures

Full Information

NCT ID

NCT05192239

First Posted

December 31, 2021

Last Updated

August 29, 2022

Sponsor

Christopher Bell

1. Study Identification

Unique Protocol Identification Number

NCT05192239

Brief Title

Influence of Edible Marijuana on Endurance Exercise Performance

Official Title

Influence of Edible Marijuana on Endurance Exercise Performance

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 9, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Christopher Bell

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endurance Exercise

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.

Masking

ParticipantInvestigator

Masking Description

Coded envelope.

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout.

Arm Title

10 mg THC

Arm Type

Active Comparator

Arm Description

Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout.

Intervention Type

Drug

Intervention Name(s)

THC 5

Other Intervention Name(s)

Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).

Intervention Description

5 milligrams of THC in gummy form

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Welch Fruit Snack

Intervention Description

Commercially available non-THC fruit snack

Primary Outcome Measure Information:

Title

Comparison of Blood Lactate Levels during a 24 minute graded standard exercise test (50 watts, 100 watts, and 150 watts) to placebo.

Description

Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula.

Time Frame