AzTrials
AzTrials

Pro and Anti Inflamatory CytokinesPhase 2/3CBD-BJJ-RCTNCT07552974

CBD Supplementation in Brazilian Jiu-Jitsu Athletes

A Phase 2/3 study testing CBD Isolate 100mg BID in people with Pro and Anti Inflamatory Cytokines and Pain, run by Associação Pan-Americana Multidisciplinar de Endocanabinologia at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pro and Anti Inflamatory Cytokines, Pain, Sleep
What is being tested?
CBD Isolate 100mg BID
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteBrazil
Study dates
1 Jan 2027to 31 Jul 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jose Wilson N V Andrade, MD contact

+55 11 971905328

dr.jwilsonandrade@gmail.com

Brazil1 site
  • APMC

    São Paulo, São Paulo, 09060-650

    Aletheia B Pablos, PhD, +55 11997426485, theiabpablos@hotmail.com

Other trials in Brazil

About this study

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

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.

Read more

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.

Read the 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).

Being tested
CBD Isolate 100mg BID, Placebo
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBD Isolate 100mg BIDDrug

    Also called CBD200

    Treated for 12 weeks

  • PlaceboOther

    Also called PLACEBOBID

    Equivalent volume of MCT BID

Study groups in NCT07552974
Study groupRoleWhat they receive
Arm CBD, recieving 100mg BIDExperimentalCBD 200mg daily
Receives: Drug: CBD Isolate 100mg BID
Placebo, recieving MCT OIL (equivalent volume of 100mg of CBD) BIDPlacebo comparatorPlacebo BID
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory cytokines

    Serum levels of pro-inflammatory cytokines (IL-6) and anti-inflammatory cytokine (IL-10), measured by ELISA/multiplex. (pg/mL)

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (4)
  1. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. 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.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. 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).

    Measured: From enrollment to the end of treatment at 12 weeks

  4. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07552974
Sponsor's protocol ID
APMCRCTBJJ
Acronym
CBD-BJJ-RCT
Status last verified
Jul 2026
First submitted
15 Apr 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CBD Isolate 100mg BID in people with Pro and Anti Inflamatory Cytokines and Pain, run by Associação Pan-Americana Multidisciplinar de Endocanabinologia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose Wilson N V Andrade, MD (+55 11 971905328, dr.jwilsonandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory cytokines (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in