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

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

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • São Paulo
      • São Paulo, São Paulo, Brazil, 09060-650

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • CBD200
Placebo Comparator: Placebo, recieving MCT OIL (equivalent volume of 100mg of CBD) BID
Placebo BID
Equivalent volume of MCT BID
Other Names:
  • PLACEBOBID

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jose Wilson N V Andrade, MD, APMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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.

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