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Not yet recruiting NCT07552974

CBD Supplementation in Brazilian Jiu-Jitsu Athletes

Phase II / Phase III Interventional Pro and Anti Inflamatory Cytokines Pain Sleep Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBD Isolate 100mg BID, Placebo.
Who it may be relevant to
Registry conditions: Pro and Anti Inflamatory Cytokines, Pain, Sleep, Quality of Life. Basic parameters: 18 years — 40 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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).

Interventions

  • Drug CBD Isolate 100mg BID
    Treated for 12 weeks
  • Other Placebo
    Equivalent volume of MCT BID

Primary outcome measures

  • Inflammatory cytokines [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (4)
  • Pain change from baseline. Visual Analogue Scale (VAS) [Time frame: 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]
  • Improvement in quality of life [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • APMC — São Paulo

Identifiers

NCT: NCT07552974 · APMCRCTBJJ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗