A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000047751
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 60
Not provided
1) Subjects who contract sexual dysfunction (erectile dysfunction, etc.). 2) Subjects who contract, are under treatment for serious diseases (e.g., diabetes, kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. 3) Subjects who have a chronic disease and regularly use medications. 4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) Subjects who are judged as unsuitable for the current study by screening test. 6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims). 7) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking 4 or more days per week. 8) Subjects who can't stop drinking from a day before each measurement. 9) Subjects who have declared allergic reaction to ingredients of test food. 10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 11) Subjects who are shiftworker and/or midnight-shift worker. 12) Subjects who plan to travel abroad, including overseas travel, during test periods. 13) Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method questionnaire
- Secondary Outcome Measures
Name Time Method