4.2. Participants
allergies, diabetes
METABOLIC DISORDER, MAY, DYSLIPIDEMIA, ALLERGIES, HYPERTENSION, DIABETES
Healthy male and female volunteers with normal lipid levels and normal blood pressure were recruited nationwide in Japan via newspaper and internet advertisements between September 2021 and May 2022. The inclusion criteria were LDL-C levels in the normal range (120–160 mg/dL) and age between 20 and 65 years old. The exclusion criteria were as follows: (1) Maintenance treatment for metabolic disorder, including dyslipidemia, hypertension, and diabetes; (2) severe hepatic, renal, cardiac, respiratory, endocrinological, and metabolic disorder disease; (3) allergies; (4) heavy drinkers, more than 30 g of alcohol per day; (5) taking medicine or functional food products that may affect the lipid metabolism, including raising HDL-C or lowering LDL-C concentration, and lowering triglyceride concentration; (6) current and past smoker; (7) women in pregnancy, lactation, or planning to become pregnant during the study period; (8) person who had more than 200 mL of blood donation within 1 month or 400 mL of blood within 3 months before starting this clinical trial; (9) a person who participated in other clinical trials within the last 3 months or currently is participating in another clinical trial; (10) those who consumed more 2000 kcal per day; (11) others considered unsuitable for the study at the discretion of the principal investigator. The study was approved by the Koseikai Fukuda Internal Medicine Clinic (Osaka, Japan, IRB approval number 15000074, approval date on 18 September 2021).