- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552974
CBD Supplementation in Brazilian Jiu-Jitsu Athletes (CBD-BJJ-RCT)
Evaluation of the Effects of Isolated Cannabidiol (CBD) on Inflammation, Pain, Sleep and Quality of Life in Brazilian Jiu-Jitsu Athletes: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Brazilian Jiu-Jitsu (BJJ) is a high-intensity martial art that imposes significant physical and physiological demands on practitioners, including rigorous training and frequent competitions, which can result in chronic inflammation, delayed-onset muscle soreness (DOMS), sleep disturbances, and reduced quality of life. Effective recovery strategies are essential to optimize athletic performance and longevity in the sport.
Cannabidiol (CBD), a non-psychotomimetic phytocannabinoid derived from Cannabis sativa, has emerged as a promising therapeutic agent due to its anti-inflammatory, analgesic, anxiolytic, and neuroprotective properties.
Preclinical studies indicate that CBD modulates inflammatory pathways, such as inhibition of NF-κB and NLRP3, thereby reducing pro-inflammatory cytokines such as IL-6, TNF-α, IL-8, and IL-1β, while increasing the anti-inflammatory cytokine IL-10.
In clinical contexts, CBD has shown potential to attenuate DOMS and improve sleep without the adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs). However, evidence in BJJ athletes remains limited, with gaps in the translation of preclinical findings to healthy athletic populations.
The prevalence of injuries in combat sports can reach 28%, with contusions and sprains being common and further exacerbating inflammation and pain. Although approximately 23.4% of athletes report cannabis use, there is a lack of randomized controlled trials (RCTs) specifically for BJJ evaluating isolated CBD at standardized doses.
Furthermore, concerns regarding hepatotoxicity, monitored through enzymes such as AST and ALT, require rigorous safety evaluation.
This protocol describes an RCT to investigate the effects of 200 mg/day of isolated CBD for 12 weeks in BJJ athletes, focusing on sensitive inflammatory markers (IL-6 as the primary pro-inflammatory marker and IL-10 as the anti-inflammatory marker), pain, sleep, and quality of life.
The study aims to address gaps identified in systematic reviews and provide an evidence-based foundation for future recommendations.
Study Overview
Status
Intervention / Treatment
Detailed Description
Abstract Objective: To evaluate the effects of chronic supplementation with isolated cannabidiol (CBD) on inflammatory markers, pain perception, sleep quality, and quality of life in Brazilian Jiu-Jitsu (BJJ) athletes in a randomized, double-blind, placebo-controlled clinical trial.
Methods: One hundred and twenty-eight BJJ athletes (aged 18-40 years, with a minimum of 2 years of practice and training ≥3 times per week) will be recruited. Participants will be randomized in a 1:1 ratio to receive 100 mg of isolated CBD or placebo twice daily (total 200 mg/day) for 12 weeks.
Primary Outcomes: Serum levels of pro-inflammatory cytokines (IL-6, TNF-α, IL-8, IL-1β) and the anti-inflammatory cytokine (IL-10), measured by ELISA or multiplex assays.
Secondary Outcomes: Pain (Visual Analog Scale - VAS), sleep quality (Pittsburgh Sleep Quality Index - PSQI), quality of life (SF-36 and Athlete Life Quality Scale - ALQS), and safety (hepatic enzyme AST).
Assessments will be conducted at baseline and at weeks 4, 8, and 12. Statistical Analysis: Linear mixed-effects models for repeated measures will be used, with the intention-to-treat (ITT) population as the primary analysis.
Expected Results: Significant reduction in inflammatory markers and improvement in secondary outcomes in the CBD group, with an acceptable safety profile.
Keywords:
Cannabidiol; Brazilian Jiu-Jitsu; Inflammation; Muscle Pain; Sleep; Quality of Life.
Introduction Brazilian Jiu-Jitsu (BJJ) is a high-intensity martial art that imposes significant physical and physiological demands on practitioners. Rigorous training and frequent competitions can lead to chronic inflammation, delayed-onset muscle soreness (DOMS), sleep disturbances, and reduced quality of life. Effective recovery strategies are essential to optimize athletic performance and longevity in the sport.
Cannabidiol (CBD), a non-psychotomimetic phytocannabinoid derived from Cannabis sativa, has emerged as a promising therapeutic agent due to its anti-inflammatory, analgesic, anxiolytic, and neuroprotective properties.
Preclinical studies indicate that CBD modulates inflammatory pathways, such as inhibition of NF-κB and NLRP3, reducing pro-inflammatory cytokines such as IL-6, TNF-α, IL-8, and IL-1β, while increasing the anti-inflammatory cytokine IL-10.
In clinical settings, CBD has demonstrated potential to attenuate DOMS and improve sleep without the adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs). However, evidence specifically in BJJ athletes remains limited, with significant gaps in translating preclinical findings to healthy athletic populations.
The prevalence of injuries in combat sports can reach 28%, with contusions and sprains being common and further exacerbating inflammation and pain. Although approximately 23.4% of athletes report cannabis use, there is a lack of randomized controlled trials (RCTs) specifically designed for BJJ evaluating isolated CBD at standardized doses.
Furthermore, concerns regarding hepatotoxicity, monitored through liver enzymes such as AST and ALT, require rigorous safety assessment.
This protocol describes a randomized controlled trial to investigate the effects of 200 mg/day of isolated CBD for 12 weeks in BJJ athletes, focusing on sensitive inflammatory markers (IL-6 as the primary pro-inflammatory marker and IL-10 as the anti-inflammatory marker), pain, sleep, and quality of life.
The study aims to address gaps identified in systematic reviews and provide an evidence-based foundation for future recommendations.
Materials and Methods Study Design This is a randomized, double-blind, placebo-controlled clinical trial with two parallel groups (CBD vs. placebo) lasting 12 weeks. Randomization will be stratified by sex and training level (2-5 years vs. >5 years), generated by computer (R software, blockrand package) in a 1:1 ratio.
Blinding will involve participants, investigators, and assessors, with interventions identical in appearance, packaging, and taste. The study will follow CONSORT guidelines and will be registered on an international platform (ClinicalTrials.gov).
Study Population One hundred and twenty-eight BJJ athletes will be recruited through partner academies in São Paulo, Brazil. The sample size was calculated to detect a 30% reduction in IL-6 (standard deviation 40%, α = 0.05, power 80%, with adjustment for 15% dropout).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Jose Wilson N V Andrade, MD
- Phone Number: +55 11 971905328
- Email: dr.jwilsonandrade@gmail.com
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 09060-650
- APMC
-
Contact:
- Aletheia B Pablos, PhD
- Phone Number: +55 11997426485
- Email: theiabpablos@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 40 years;
- Minimum 2 years of BJJ practice;
- Training at least 3 times per week;
- Free from injuries that prevent training or competition;
- No current or recent cannabis use;
- Signed Informed Consent Form (ICF).
Exclusion Criteria:
- History of hepatic, renal, or cardiovascular diseases;
- Use of medications that may interact with CBD (e.g., anticoagulants);
- Allergy or known hypersensitivity to cannabinoids;
- Pregnancy or planning to become pregnant;
- Participation in another clinical study within the last 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm CBD, recieving 100mg BID
CBD 200mg daily
|
Treated for 12 weeks
Other Names:
|
|
Placebo Comparator: Placebo, recieving MCT OIL (equivalent volume of 100mg of CBD) BID
Placebo BID
|
Equivalent volume of MCT BID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory cytokines
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Serum levels of pro-inflammatory cytokines (IL-6) and anti-inflammatory cytokine (IL-10), measured by ELISA/multiplex.
(pg/mL)
|
From enrollment to the end of treatment at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain change from baseline. Visual Analogue Scale (VAS)
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Measure with Visual Analogue Scale.
Scoring (0-100mm line): 0 mm to 4 mm indicates no pain, 5 mm to 44 mm is mild pain, 45 mm to 74 mm is moderate pain, and 75 mm to 100 mm is severe pain.
|
From enrollment to the end of treatment at 12 weeks
|
|
Sleep quality improvement from baseline
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Measured with the PSQI. Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month interval. The measure consists of 19 individual items, creating 7 components that produce a global score. In English, when describing the PSQI scoring categories, we typically use the following phrasing: Scoring Categories: 0 to 5 points: Good sleep quality. 6 to 10 points: Poor sleep quality. 11 to 15 points: Very poor sleep quality. 16 to 21 points: Extremely poor sleep quality. |
From enrollment to the end of treatment at 8 weeks
|
|
Improvement in quality of life
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Measured with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF 36).
The SF-36 is a generic quality-of-life questionnaire consisting of 36 items that assess 8 physical and mental health domains.
Widely used and easy to administer (taking 5 to 10 minutes), it is scored from 0 (worst health) to 100 (best health).
|
From enrollment to the end of treatment at 12 weeks
|
|
Athlete Quality Of Life
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Mesured with the Athlete Life Quality Scale (ALQS).
A 15-item, validated tool developed by N.B.
Gentner in 2004 to measure the holistic well-being of collegiate athletes.
It assesses five key factors: general life satisfaction, physical satisfaction, team/sport satisfaction, primary social satisfaction, and recovery/social satisfaction.
higher rates indicate ing a higher level of satisfaction.
|
From enrollment to the end of treatment at 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jose Wilson N V Andrade, MD, APMC
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- APMCRCTBJJ
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.
Clinical Trials on Quality of Life
-
Ziekenhuis Oost-LimburgRecruitingQuality of Life | Postoperative Quality of Recovery | Health-Related Quality-of-LifeBelgium
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Istituto Ortopedico RizzoliUniversity of BolognaCompletedImprove Quality of LifeItaly
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
Clinical Trials on CBD Isolate 100mg BID
-
Vedic Lifesciences Pvt. Ltd.Recruiting
-
University of Texas at AustinSuspendedPost Traumatic Stress DisorderUnited States
-
University of ManitobaCanadian Institutes of Health Research (CIHR); Research ManitobaNot yet recruitingDrug Resistant Epilepsy
-
University of Texas at AustinWay West Wellness; SunFlora.IncSuspendedAnger | Sleep Disturbance | Anxiety Depression | Substance Abuse | Alcohol Abuse | Stress ReactionUnited States
-
SOM Innovation Biotech SACompleted
-
University of ReginaNational Football League (NFL); My Next Health Inc.Completed
-
University of OklahomaNot yet recruiting
-
Colorado State UniversityCompletedPharmacokinetics | Metabolism | Liver FunctionUnited States
-
GlaxoSmithKlineTerminatedHIV-1Australia, Belgium, Canada, France, Germany, Greece, Italy, Spain, United Kingdom
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina