Healthy adult
Conditions
Interventions
Continuous intake of ONO-DA for four weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Male participants who are aged 40 years or older and less than 65 years at the time of obtaining informed consent (2) Body mass index (BMI) at screening is greater than or equal to 18.5 kg/m2 and less than 27.0 kg/m2 (3) Participants who are able to provide hair samples for hair hormone analysis (4) Participants who fully understand the purpose and details of the study and provide written informed consent to participate
Exclusion criteria
Exclusion criteria: (1) Participants who routinely consume health food products rich in shark liver oil, DHA, or EPA at least once per week (2) Participants who regularly consume fish four or more times per week (3) Participants who routinely use medications, including over-the-counter or prescription drugs, as well as herbal (Kampo) medicines (4) Participants with diseases currently under treatment (5) Participants with a history of serious diseases (e.g., diabetes mellitus, liver disease, renal disease, or cardiovascular disease) (6) Participants with known or suspected allergies related to the study (e.g., fish, shrimp, crab, or fish roe) (7) Participants who have participated in another clinical study or trial within one month prior to obtaining informed consent (8) Participants who are unable to refrain from hair dyeing, bleaching, or perming from one month prior to the pre-intake examination (9) Participants suspected of late-onset hypogonadism (LOH) based on pre-screening hormone tests (a total testosterone level of less than 250 ng/dL or a free testosterone level of less than 8.5 pg/mL), or deemed appropriate for testosterone replacement by the investigator (10) Participants who are judged unsuitable for the study based on the results of clinical and physical examinations at screening (11) Participants who are judged unsuitable for the study based on the results of a lifestyle questionnaire (12) Participants who are judged by the investigator to be unsuitable for the study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transcript expression patterns | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormonal balance, lipid metabolism, subjective assessment | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed