Healthy subjects
Conditions
Interventions
Take test food A on the day of the test. Wash out (2 weeks or more) Take placebo food on the day of the test. Wash out (2 weeks or more) Take test food B on the day of the test.
Take test food B o
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Japanese males who are between 40 and 70 years old at the time of obtaining written consent. 2.Subject with serum free testosterone levels below 11.8 pg/ml. 3.Subject who can drink moderate amounts of alcohol (about 500ml of beer). 4.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who has been diagnosed as an alcoholic by a physician. 2.Subject who is taking medication or under medical treatment due to serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who may develop allergies due to the test foods. 5.Subject with current or history of drug dependence. 6.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past. 7.Subject with irregular life rhythms due to night shifts or shift work. 8.Subject with extremely irregular lifestyle habits such as eating and sleeping. 9.Subject who has an extremely unbalanced diet. 10.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 11.Subject who uses health foods, supplements, and medicines that affect male hormone. 12.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 14.Subject who can't keep the daily records. 15.Subject who is judged as an inappropriate candidate according to the screening data. 16.Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum free testosterone, Drunkenness VAS Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Serum testosterone, serum DHEA-S, serum cortisol, plasma ACTH, blood lactate, blood pyruvate, serum creatinine, plasma glucose, serum uric acid, serum TG, serum amino acids, blood acetic acid, breath alcohol content. (Safety evaluation) Vital signs, physical measurements, adverse events. | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Public Relations Department
Outcome results
None listed