A Phase 2/3 interventional study of CBD Isolate 100mg BID and Placebo in Pro and Anti Inflamatory Cytokines, Pain and Sleep, sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia. Not yet recruiting at 1 site in Brazil. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Associação Pan-Americana Multidisciplinar de Endocanabinologia · Phase 2/3, Interventional, and Treatment
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.
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).
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Associação Pan-Americana Multidisciplinar de Endocanabinologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
CBD 200mg daily
Drug: CBD Isolate 100mg BID
Placebo BID
Other: Placebo
Treated for 12 weeks
Also known as: CBD200
Equivalent volume of MCT BID
Also known as: PLACEBOBID
Inflammatory cytokines
Serum levels of pro-inflammatory cytokines (IL-6) and anti-inflammatory cytokine (IL-10), measured by ELISA/multiplex. (pg/mL)
Time frame: From enrollment to the end of treatment at 12 weeks
Pain change from baseline. Visual Analogue Scale (VAS)
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Sleep quality improvement from baseline
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.
Time frame: From enrollment to the end of treatment at 8 weeks
Improvement in quality of life
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).
Time frame: From enrollment to the end of treatment at 12 weeks
Athlete Quality Of Life
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: No
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Associação Pan-Americana Multidisciplinar de Endocanabinologia