CBD Supplementation in Brazilian Jiu-Jitsu Athletes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CBD Isolate 100mg BID, Placebo.
- Кому может быть актуально
- Состояния в реестре: Pro and Anti Inflamatory Cytokines, Pain, Sleep, Quality of Life. Базовые параметры: 18 лет — 40 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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).
Вмешательства
- Препарат CBD Isolate 100mg BID
Treated for 12 weeks - Другое Placebo
Equivalent volume of MCT BID
Первичные конечные точки
- Inflammatory cytokines [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Вторичные конечные точки (4)
- Pain change from baseline. Visual Analogue Scale (VAS) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Sleep quality improvement from baseline [Срок оценки: From enrollment to the end of treatment at 8 weeks]
- Improvement in quality of life [Срок оценки: From enrollment to the end of treatment at 12 weeks]
- Athlete Quality Of Life [Срок оценки: From enrollment to the end of treatment at 12 weeks]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Бразилия · 1 центр
- APMC — São Paulo
Идентификаторы
NCT: NCT07552974 · APMCRCTBJJ