2.1. Study Design and Participants
RECRUITMENT
A detailed description of the study design, procedures, participant recruitment, and randomization was previously described and published [The study included 27 participants in free-living conditions who were randomly assigned to 2 study sequences, either fermented soy powder followed by the control brown rice powder or vice versa in a typical crossover fashion. Participants were enrolled at 3 separate time points. Participants were instructed to maintain their usual physical activity levels and consistent lifestyle habits during the study period. Of 61 subjects screened, 29 were randomized and 2 participants dropped out for lack of interest. A flow chart of participants is shown in The study was conducted at the Nutrition Research Center of Loma Linda University (LLU) in Loma Linda, CA. The study protocol and relevant documents were approved by the Institutional Review Board of Loma Linda University before the initiation of the trial, and participants provided written informed consent before enrolling in the study. This clinical trial was conducted according to the ethical study guidelines of the Declaration of Helsinki of 1975 as revised in 1983. The study was registered at ClinicalTrials.gov as NCT03429920.