None listed
Conditions
Interventions
Others(Functional food) : The subject are randomly assigned to either the test group or the control group according to the order of registration and consumed the product for 12 weeks.
- Rubus occident
Sponsors
Berry&Bio Food Research Institue
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged between the 40 and 75 years 2. Andropause symptoms ? AMS survey result of 27 points or more ? As a result of the ADAM survey, if question 1 or 7 is “yes” or 3 or more of the other questions are “yes” 3. Those with TT (Total Testosterone) 2.51 ng/ml or more and 10.63 ng/ml or less 4. After listening to the detailed explanation of this clinical trial and fully understanding, a person who consented to participate in this clinical trial and signed a informed consent
Exclusion criteria
Exclusion criteria: 1. Those who have received testosterone or testosterone inhibitors within 2 months 2. Those who received intramuscular testosterone within 6 months 3. BMI (Body Mass Index) 30 kg/m2 or more 4. T-PSA (Total Prostate Specific Antigen) 4.0 ng/ml or more 5. hyperprolactinemia (blood prolactin is 3 times or more of the upper limit of the reference range) 6. Severe acute or chronic cardio-cerebrovascular disease, metabolic disease, liver and biliary tract disease, pancreatic disease, muscle disease, neurological disease, mental disease, endocrine system disease, immune disease, kidney disease, malignant tumor, lung disease, urinary system diseases, and other diseases 7. Diagnosed with diabetes or those with an HbA1c of 6.5% or more 8. Those with hypotension below 90/50 mmHg or uncontrolled hypertension above 160/100 mmHg 9. A person who has taken medication or used treatment to improve and treat male menopause, sexual function, impotence, enlarged prostate, etc. within 2 months 10. A person who has taken health functional foods and herbal medicines to improve male menopause, sexual function, impotence, enlarged prostate, etc. within 2 weeks 11. Those who have a history of hypersensitivity or clinically significant hypersensitivity to components of drugs and products for human application 12. Those with a history of gastrointestinal diseases (e.g., Crohn's disease, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of products for clinical trial 13. Those with a history of alcoholism or substance abuse 14. Those who have been diagnosed with antipsychotics or who have received drug treatment within 2 months 15. Those who participated in other clinical trials within 2 months 16. Lab test - AST, ALT > 3 times or more of the upper limit of the reference range - Serum creatinine > 2.0 mg/dl 17. A person who determines that the investigator is inappropriate for clinical trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| IPSS survey, ADAM survey;hormone index(TT, FT, BT, SHBG, FSH, LH), lipid index(TC, TG, HDL-C, LDL-C), body measurements index(body weight, BMI, BFM, PBF, FFM, WC, HC, WHR);adverse event, physical examination, lab test, electrocardiogram, vital sign | — |
Primary
| Measure | Time frame |
|---|---|
| ASM survey | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Ock Park
Jeonbuk National University Hospital
Outcome results
None listed