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Topical Cannabidiol Cream and Post-exercise Recovery

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ClinicalTrials.gov Identifier: NCT05044936
Recruitment Status : Not yet recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:
This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

Condition or disease Intervention/treatment Phase
Muscle Damage Drug: Cannabidiol Oil Other: Resistance Exercise Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated Measures
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Training
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




Primary Outcome Measures :
  1. Change in indirect markers of muscle damage [ Time Frame: 24 & 48 hours post-training ]
    Measuring lactate dehydrogenase blood levels

  2. Change in indirect markers of muscle damage [ Time Frame: 24 & 48 hours post-training ]
    Measuring creatine kinase blood levels

  3. 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

  4. Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]
    Measure differences in maximum voluntary contraction.

  5. Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]
    Measure differences in vertical jump

  6. Change in exercise performance [ Time Frame: 24 & 48 hours post-training ]
    Measure differences in sprint time



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, recreationally trained young adult-aged females and males
  • Been engaging in resistance training (> 2 days/weeks for > 6 months)
  • Classified as "low risk" according to criteria put forth by American College of Sports Medicine

Exclusion Criteria:

  • Cardiovascular, metabolic, viral, kidney, liver disease, or acute orthopedic injuries
  • Pregnant or planning to become pregnant during the study
  • Unable to consent
  • Under 18 years of age
  • Over 35 years of age
  • Prisoners
  • Participants with cognitive impairment or with legally authorized representative

Information from the National Library of Medicine

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


Contacts
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Contact: Fabiano Amorim, PhD (505) 277-3795 amorim@unm.edu

Locations
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United States, New Mexico
UNM Exercise Physiology Lab
Albuquerque, New Mexico, United States, 87131
Contact: Fabiano T Amorim, PhD    505-277-3795    amorim@unm.edu   
Principal Investigator: Fabiano T Amorim, PhD         
Sub-Investigator: Rogelio A Realzola, MS         
Sponsors and Collaborators
University of New Mexico
Investigators
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Study Chair: Fabiano Amorim, PhD University of New Meixoco
Publications:

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT05044936    
Other Study ID Numbers: CBD2021
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of New Mexico:
Exercise
Resistance training
Canabidiol
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants