2.2. Subjects
obesity, gastrointestinal symptoms, a fasting blood glucose, arrhythmia, heart disease, heartburn, indigestion, hemorrhage, fermented milk, psychiatric, diabetic, hypoglycemic, angina pectoris, cerebral infarction
OBESITY, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, ARRHYTHMIA, HEART DISEASE, CENTRAL NERVOUS SYSTEM DISORDERS, DISORDERS, MUSCULOSKELETAL DISORDERS, HEMORRHAGE, HEART FAILURE, CEREBRAL INFARCTION, CEREBROVASCULAR DISEASE
The clinical trial was conducted from June 2018 to November 2019 at Inje University Seoul Paik Hospital in compliance with the Helsinki Declaration and Korean Good Clinical Practice guidelines. The clinical trial was approved by the Institutional Review Board (IRB No. PAIK 2018-04-004), and registered at the Clinical Research Information Service of South Korea (Approval Number: KCT0003222). A total of 100 subjects were recruited after screening (physical and laboratory examinations). All subjects provided informed consent prior to the initiation of the clinical trial. The following selection criteria were used: (1) male and female subjects aged ≥20 and ≤60 years old; (2) those with a BMI of ≥25 kg/mThe exclusion criteria for clinical trial subjects were: (1) those who suffered from or were diagnosed with severe cerebrovascular disease (including cerebral infarction and hemorrhage) or heart disease (angina pectoris, myocardial infarction, heart failure, and arrhythmia) within the last six months; (2) patients with uncontrolled hypertension (blood pressure ≥ 160/100 mmHg); (3) persons with a fasting blood glucose level of ≥126 mg/dL, a random blood glucose level of ≥200 mg/dL, or a diabetic patient taking oral hypoglycemic agents or insulin; (4) persons with thyroid stimulating hormone levels of ≤0.1 µU/mL or ≥10 µU/mL; (5) those whose creatinine level was more than twice the normal upper limit; (6) those whose aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were more than three times the normal upper limit; (7) those who complained of severe gastrointestinal symptoms, such as heartburn and indigestion; (8) those who had been taking drugs that affect body weight (absorption inhibitors and appetite suppressants, supplements related to obesity improvement, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month; (9) those who had continuously consumed probiotics (fermented milk) within the last week; (10) those who had lost ≥3 kg within four weeks of screening; (11) those who had participated in a commercial obesity program within the last three months; (12) those who had participated or planned to participate in other clinical studies within the month before clinical screening; (13) those who had been hospitalized or were undergoing drug treatment or rehabilitation treatment for disorders induced by alcohol use, heart disease, or central nervous system disorders identified through a medical history survey; (14) those who were deemed unable to exercise due to musculoskeletal disorders; (15) those who were pregnant or planning to become pregnant during this clinical study or lactating women; and (16) those deemed ineligible by the clinical trial manager for other reasons.