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临床试验/NCT05192239
NCT05192239已完成早期 1 期

Influence of Edible Marijuana on Endurance Exercise Performance

Christopher Bell1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年12月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
17
试验地点
1
主要终点
Comparison of Maximal Mean Power Output to Placebo

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Coded envelope.

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the age of 21 and
  • 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.

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

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.

干预措施: THC 5 (Drug)

结局指标

主要结局

Comparison of Maximal Mean Power Output to Placebo

时间窗: 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 Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

时间窗: 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.

时间窗: 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 Time to Exhaustion to Placebo

时间窗: 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

Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christopher Bell

Associate Professor

Colorado State University

研究点 (1)

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