Discussion
DOMS
CONTRACTION
The primary aim of this pilot study was to examine the safety and tolerability of a CBD- and CBG-based formulation that was developed to enhance recovery among exercise-trained individuals who self-reported exercising at least 3 times per week for at least 30 minutes per session for the past year. There were no safety concerns and no unexpected interactions among the multiple ingredients in the formulation. Self-reported compliance with formulation consumption over 3.5 days of dosing at home was excellent. Thus, the first test of this formulation in a small sample of exercise-trained individuals indicated a good safety and tolerability profile.The formulation showed a signal for modest effects on decreased self-reported average soreness/discomfort 72 hours post-DOMS, complementing previous supportive findings of the effect of CBD on recovery [CBG is an understudied cannabinoid that is increasingly found in products marketed to athletes as promoting recovery for its potential anti-inflammatory properties [Although a unique aspect of this pilot study was the examination of CBG in humans, CBG was only one ingredient in the evaluated formulation. Perhaps the most significant limitation of this study was that the formulation contained multiple ingredients, making it impossible to isolate which ingredient(s) drove preliminary effects on recovery. Another limitation is that formulation dosing prior to the DOMS induction may not reflect how individuals would consume a product for recovery-related purposes in the real world. This study recruited exercise-trained participants who self-reported exercising at least 3 times per week for at least 30 minutes per session for the past year, and findings may not generalize to non-exercise-trained individuals or to those with a different training volume. The study included a large number of outcomes across multiple time points. No adjustment to confidence interval widths was implemented because this was a pilot study; false positive interpretations of effect sizes as indicative of potential clinical meaningfulness are possible, especially for outcomes for which a consensus MCID is not established. Future evaluations in larger samples would benefit from assessment of whether the blinding of the study formulation was adequate (e.g. ask participants to guess which formulation they consumed and why they guessed that formulation), objective assessment of compliance with formulation consumption (e.g. cannabinoid concentrations in plasma and urine), and assessment of compliance with instructions on consumption of the formulation (e.g. whether the powder was mixed with water as instructed or with a different liquid; whether the participant consumed the formulation after a meal as instructed or on an empty stomach).The findings of this pilot study have implications for design of future DOMS trials. The observed standard deviation on post-DOMS average/soreness was larger than anticipated based on previous literature. This may be a result of different DOMS induction methods in the current vs. some previous studies (upper body eccentric contraction vs. lower body eccentric contraction; running; cycling). Future trial design should select a standard deviation estimate for power/precision analysis based on prior studies using similar DOMS induction approaches. As complete symptom resolution was not achieved by the 72-hour assessment for most outcomes, future trials may extend the duration of follow-up to capture resolution of more persistent symptoms or evaluate possible cumulative effects over time. Future trials may adopt a dismantling design to compare the formulation tested here to its constituent ingredients and help determine which component(s) drive effects on recovery. Although effects on sleep and mood were not observed, a different pattern might emerge among exercise-trained individuals who report baseline disturbance in sleep or mood.Results from this pilot study revealed a good safety and tolerability profile associated with a beverage powder containing CBD, CBG, BCP, BCAAs, and magnesium citrate. Preliminary results on effects suggested that repeated-dosing of this cannabinoid-based formulation over 3.5 days improved functional aspects of recovery, and could decrease self-reported soreness or discomfort, associated with DOMS.