2.1. Clinical Trial Design
neuropsychiatric disorders
ORGANIC DISEASE
This study is a double-blind, placebo-controlled clinical trial. The Institutional Review Board of China Medical University Hospital (CMUH, Taichung, Taiwan) approved the study (CMUH111-REC3-127), and written informed consent was obtained from the subjects. The ClinicalTrials.gov identifier for this study is NCT05988593. For this study, we recruited 64 healthy adults. The inclusion criteria were healthy adult males or females aged 20 to 65. The exclusion criteria were: (1) breastfeeding, pregnant or planning to become pregnant during the trial (self-reported), (2) heart, liver, kidney, endocrine, or other major organic diseases (self-reported), (3) long-term medication use (self-reported), (4) neuropsychiatric disorders or brain surgery, (5) inability to see 12-point font on a computer clearly after vision correction. Subjects were randomly assigned to either the formula-beverage or placebo group. In total, 64 subjects were recruited, with 32 placed in the Formula beverage and 32 in the placebo group. The manufacturer kept the unblinding forms of the numbers, obtained after the experiment’s completion, for data analysis.