None listed
Conditions
Interventions
Dietary Supplement : 1) test product
- Main character: purple corn extract
- Properties and formulations: hard capsules containing a dark purple powder that is already odorless and has its own flavor
Sponsors
Hallym University Medical Center-Dongtan
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men aged 40 years or older and 80 years or less at the time of screening tests 2) Men with lower urinary tract symptoms of septum with an international prostate symptom score (IPSS) total score of 19 or less 3) After hearing and fully understanding the detailed description of this human application test, the person who voluntarily decides to participate and agrees to comply with the precautions
Exclusion criteria
Exclusion criteria: 1) Subjects who have experienced adverse reactions, such as hypersensitivity reactions and allergies, to ingredients contained in food for human application testing 2) A person who has clinically significant acute or chronic cardio-cerebrovascular relationship, endocrine system, immune system, respiratory system, biliary system, kidney and urinary system, nervous system, psychiatric system, musculoskeletal system, inflammatory and blood/tumor, gastrointestinal disease, etc 3) Those whose maximum urination rate is less than 5 mL/sec or more than 15 mL/sec 4) Those whose residual urine volume exceeds 150 mL 5) Prostate-specific antigens (PSA) in the blood not less than 4 ng/mL 6) Those who have undergone urogenital-related surgery, including prostate surgery, and other invasive procedures for prostate treatment (such as meniscus acupuncture, prostate laser treatment, etc.) 7) A person with a prostate volume of less than 20 mL on ultrasound of the rigid intestine prostate 8) a person diagnosed with prostate cancer or bladder cancer 9) Those who have consumed prostatic hypertrophy drugs and health functional foods within 4 weeks of screening criteria (5a-reducing enzyme inhibitors, alpha blockers, anticholinergics, somalmetho, etc.) 10) Patients with uncontrolled hypertension (160/100 mmHg or more) and patients with uncontrolled diabetes (if they start medication due to diabetes at least 160 mg/dL per fasting blood and within the last 3 months) 11) A person who participated in another human body application test and consumed food for testing in the past three months 12) Those who show the following results in diagnostic laboratory medical examination - AST, ALT > 3 times the reference value - Serum creatine > 2.0 mg/dL 13) A person who has a history of alcoholism and substance abuse or is suspected 14) A person who is in charge of human body application testing due to diagnostic test medical examination results and other reasons is deemed inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| international prostate symptom score | — |
Secondary
| Measure | Time frame |
|---|---|
| OABSS score;blood PSA;blood testosterone;Convex Inspection (maximum, average;the amount of urination left after urination;IIEF Score;NIH-CPSI score;Monitoring of Abnormal Reactions;diagnostic examination;vital signs;a physical examination | — |
Countries
Korea, Republic of
Contacts
Public Contactjonggeun kim
Hallym University Medical Center-Dongtan
Outcome results
None listed