2.2. Subjects
AMS, androgen deficiency
ANDROGEN DEFICIENCY
Volunteers aged 40 to 75 years were recruited from the Clinical Trial Center for Functional Foods (CTCF2) at Jeonbuk National University Hospital (JBUH) through internal advertising, including internet postings on departmental home pages, brochures, and posters, between 20 August 2019 and 2 December 2020. The study was approved by the Institutional Review Board (IRB) of JBUH (IRB No.2019-04-063) and registered with the Clinical Research Information Service of the Republic of Korea (approval number: KCT0008306). The clinical trial was conducted in compliance with the Helsinki Declaration and the Korean Good Clinical Practice (KGCP) provisions. The participants signed a consent form and underwent a screening assessment. A total of 30 participants were selected after undergoing screening tests, including questionnaires, physical examinations, and laboratory examinations. The selected participants were enrolled 3 weeks before receiving the test supplement. The criteria for selecting subjects were as follows: (1) men aged 40 to 75 years; (2) MCS, as determined by an aging males’ symptoms (AMS) scale score of 27 or higher; (3) based on the androgen deficiency in aging males (ADAM) questionnaire where participants’ answers for questions 1 or 7 are “yes,” or 3 or more of the other questions are “yes”; (4) total testosterone (TT) level between 2.51 ng/mL and 10.63 ng/mL; and (5) volunteers with understanding on the objectives of the study and agreeing to adhere by study rules throughout the study.Exclusion criteria were (1) participants who had received testosterone or testosterone inhibitors within the previous 2 months; (2) participants who had received intramuscular testosterone within the previous 6 months; (3) participants with a body mass index (BMI) of 30 kg/m