CBD Supplementation in Brazilian Jiu-Jitsu Athletes

NCT07552974 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: APMCRCTBJJ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Sleep; Pro and Anti Inflamatory Cytokines; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Inflammatory cytokines

  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 Outcomes (4)

• Pain change from baseline. Visual Analogue Scale (VAS)

  From enrollment to the end of treatment at 12 weeks

• Sleep quality improvement from baseline

  From enrollment to the end of treatment at 8 weeks

• Improvement in quality of life

  From enrollment to the end of treatment at 12 weeks

• Athlete Quality Of Life

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Arm CBD, recieving 100mg BID

EXPERIMENTAL

CBD 200mg daily

Drug: CBD Isolate 100mg BID

Placebo, recieving MCT OIL (equivalent volume of 100mg of CBD) BID

PLACEBO COMPARATOR

Placebo BID

Other: Placebo

Interventions

CBD Isolate 100mg BID DRUG

Treated for 12 weeks

Also known as: CBD200

Arm CBD, recieving 100mg BID

Placebo OTHER

Equivalent volume of MCT BID

Also known as: PLACEBOBID

Placebo, recieving MCT OIL (equivalent volume of 100mg of CBD) BID

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associação Pan-Americana Multidisciplinar de Endocanabinologia: lead

Study Sites (1)

APMC

São Paulo, São Paulo, 09060-650, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Wilson N V Andrade, MD

  APMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Wilson N V Andrade, MD

CONTACT

+55 11 971905328; dr.jwilsonandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)