Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060666) titled 'Exploratory study of health-related functions of ONO-DA' on Feb. 13.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - EP Mediate Co., Ltd.

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To evaluate the health-related functions of daily intake of ONO-DA for four weeks Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of ONO-DA for four weeks

Eligibility: Age-lower limit - 40 years-old

Gender - Male Key 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 Key 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 Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 12 Day Date of IRB - 2026 Year 02 Month 12 Day Anticipated trial start date - 2026 Year 02 Month 19 Day Last follow-up date - 2026 Year 04 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069387

Disclaimer: Curated by HT Syndication.