2.1. Ethical Statement and Participants
allergic reaction, paralysis
RECRUITMENT, ALLERGIC REACTION
This randomized, double-blind, placebo-controlled, parallel-group study was approved by the ethics committee of the University of Tsukuba (reference no. Tai 021-120) and registered at the University Hospital Medical Information Network Center (UMIN no. R00005196). To ensure the reliability of the double-blind trial, we entrusted the recruitment and data management of the participants to a business consignment agency (e-sport corporation, Tsukuba, Japan). Middle-aged and older adults residing in Tsukuba City, Japan, were recruited over a one-month period through regional information magazines (Joyo Living Co., Ltd., Tsukuba, Japan). A screening survey was conducted via telephone interviews using self-reported, general health questionnaires. The inclusion criteria were as follows: (1) middle-aged and older adults and (2) people who can independently visit the experimental facility. Participants were excluded if they (1) had paralysis, (2) had an allergic reaction to the ingredients of the test food, (3) were participating in other clinical studies or had participated within three months, and (4) were deemed by the principal investigator to be inappropriate as participants of this study. A total of 91 middle-aged and older adults were enrolled in this study; however, 10 of these individuals were excluded in accordance with the criteria, 7 declined to participate, and 2 were hospitalized (