Healthy adults
Conditions
Interventions
Ingestion of functional food for 12 weeks
Sponsors
Kyowa Trial Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese men aged greater than or equal to 30 years, less than 80 years at the time of obtaining informed consent. 2. Subjects with IIEF-EF domain score of 11 to 21 at screening. 3. Subjects with AMS score of 27 to 49 at screening. 4. Subjects who have attempted heterosexual intercourse at least once every 4 weeks. 5. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received ED treatment or infertility treatment. 2. Subjects who have past or current medical history related to urology such as prostatic hypertrophy. 3. Subjects who have received for depression treatment or may have depression. 4. Subjects who have liver disorder, kidney disorder, heart disease, organ disorder, diabetes, hypertension, dyslipidemia, or other serious diseases. 5. Subjects who have had a history of gastrointestinal tract surgery, such as gastrectomy, gastrointestinal suture, or bowel resection. 6. Subjects have received medication. 7. Subjects who have received hormone replacement therapy. 8. Subjects who have irregular lifestyle habits due to night shift or shift work. 9. Subjects who use excessive tobacco or alcohol, or have extremely irregular eating habits. 10. Subjects who have allergies such as food allergies or asthma. 11. Subjects who regularly use drugs, specified health foods, health foods, or supplements that may affect this study. 12. Subjects who had participated in other clinical studies within the last three month prior to the current study. 13. Subjects who do not agree with the purpose of the explanation given in advance. 14. Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Various questionnaires | — |
Countries
Japan
Contacts
Public ContactYoshimichi Kohzai
Kyowa Trial Co., Ltd. President
Outcome results
None listed