Study design
MAY
This 16-week, single-center, randomized, double-blind, placebo-controlled, parallel-group, clinical study was conducted at Wonkwang University Korean Medicine Hospital in Jeonju from August 2021 to May 2022. The study protocol and informed consent form were approved by the Institutional Review Board (IRB) of Wonkwang University Korean Medicine Hospital (IRB approval No.: WUJKMH-IRB-2021-0008). This study was registered with the Clinical Research Information Service (CRIS), the Republic of Korea (Participants were recruited through several ways (banner, newspaper, Wonkwang University Korean Medicine Hospital web page, and so on). A screening visit was conducted within two weeks of the first visit to select subjects who met the inclusion & exclusion criteria. After baseline evaluation, participants were randomly assigned to test and placebo groups at a 1:1 ratio. One hundred subjects received each product at each visit every eight weeks for three visits (visit 1: week 0; visit 2: week 8; and visit 3: week 16).During the 16-week study period, subjects were asked to maintain their usual lifestyle including dietary intake and physical activity. They were asked to avoid consuming other functional foods or dietary supplements. Efficacy and safety were evaluated before and after the study period.