Study design
DOMS, muscle soreness, fatigue, pain
EVENT
This randomized, double-blind, placebo-controlled, repeated-dose pilot study was conducted between December 2021 and February 2022 at one site in the United States. Individuals were recruited from panels of participants from past studies, local advertisements, and social media targeted advertisements. Individuals completed a telephone or online screening; those who met inclusion/exclusion criteria were enrolled into the study, scheduled for the first study visit, and randomized to active vs. placebo formulation condition in a 1:1 ratio.At the first study visit, participants had their study eligibility confirmed and completed baseline assessments. To examine recovery, the first study visit involved an experimental induction of delayed onset muscle soreness (DOMS). DOMS is muscle soreness, pain, or discomfort that intensifies and peaks within one to 3 days following rigorous, unaccustomed exercise, and can also include a reduction in flexibility or mobility, decreased strength, increased fatigue, and decreased physical or athletic performance. In order for the study formulation to be in systemic circulation at the onset of the inflammatory process induced by the DOMS procedure, participants consumed the first dose of the study formulation 1 hour before undergoing the DOMS induction.Following the DOMS induction and completion of the first study visit, participants were provided with 8 doses (7 scheduled doses + 1 extra dose in the event of lost/missing dose) of the study formulation to which they had been randomly assigned (i.e. active or placebo), with instructions on consumption of the study formulation at home. Participants completed 3 follow-up visits 24-, 48-, and 72 hours after the completion of the first study visit.