Topical Cannabidiol Cream and Post-exercise Recovery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05044936|
Recruitment Status : Not yet recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Muscle Damage||Drug: Cannabidiol Oil Other: Resistance Exercise||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Repeated Measures|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Topical Cannabidiol Cream on Post-exercise Recovery|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||May 2022|
Visit 1: sign consent form, pregnancy tests for females, resting blood pressure, height/weight, body composition, and VO2max test. Visit 2: 1-repetition maximum (RM) test and protocol familiarization. Visit 3: perform a muscle-damaging exercise protocol. Pre-exercise soreness and blood samples will be collected. After, they will perform the pre-exercise testing to assess baselines levels of power and sprint times. Upon completion, they will undergo the muscle-damaging exercise protocol. Post-exercise blood samples and soreness will be collected. The participant will then be given either placebo or CBD cream to rub into their quadriceps. Visit 4 & 5: collect blood samples and soreness scale measurements. Participants will then be given the same treatment (placebo or CBD cream) as they had on visit 3. Visit 6 will be similar to visit 3, except the participant will be given the opposite treatment (placebo or CBD cream). Visits 7 & 8 will be similar to visits 4 & 5, respectively.
Drug: Cannabidiol Oil
The dose that will be used for each administration of CBD will be 0.5mg/kg of body mass. As there are no recommendations for CBD from the FDA or through previous research in humans, and especially for CBD cream, the dosage is based on the United Kingdom's governing body recommending maximal amounts of CBD ingestion being 1 mg/kg per day. Further, the "practical" amount that companies "recommend" is anywhere from a "pea size" to a "handful," which can range from high and low amounts. Using 0.5mg/kg of body mass allows for a moderate use of the lotion, as well as leaving extra quantities throughout the day should people want to use CBD outside of their post-workout recovery strategies outside of a laboratory setting. To convert the amount of CBD to the amount of lotion, we will divide the amount of CBD (0.5 mg/kg) by 4.85 (the amount of mg of CBD per gram of lotion). This will calculate the amount (in grams) of lotion each participant will receive.
Other Name: CBD
Other: Resistance Exercise
Participants will complete eccentric-based leg press (4-s lowering phase and 1-s upward phase) for 10 sets of 8 repetitions at 70% 1RM in order to induce muscle damage using a leg press machine. Three minutes of rest will be permitted between sets. Following the 10th leg press, participants will complete 4 sets of 20 consecutive plyometric lunges using only their body weight. Two minutes of rest will be permitted between sets. The muscle damaging protocol will be done upon completion of the 4th set of plyometric lunges.
Other Name: Exercise
- Change in indirect markers of muscle damage [ Time Frame: 24 & 48 hours post-training ]Measuring lactate dehydrogenase blood levels
- Change in indirect markers of muscle damage [ Time Frame: 24 & 48 hours post-training ]Measuring creatine kinase blood levels
- Change in muscle soreness [ Time Frame: 24 & 48 hours post-training ]Measuring using a soreness visual analog scale from 0-10, where 0 means no soreness, and 10 means extremely high/painful levels of soreness
- Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]Measure differences in maximum voluntary contraction.
- Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]Measure differences in vertical jump
- Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]Measure differences in sprint time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044936
|Contact: Fabiano Amorim, PhD||(505) firstname.lastname@example.org|
|United States, New Mexico|
|UNM Exercise Physiology Lab|
|Albuquerque, New Mexico, United States, 87131|
|Contact: Fabiano T Amorim, PhD 505-277-3795 email@example.com|
|Principal Investigator: Fabiano T Amorim, PhD|
|Sub-Investigator: Rogelio A Realzola, MS|
|Study Chair:||Fabiano Amorim, PhD||University of New Meixoco|