UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060666 |
|---|---|
| Receipt number | R000069387 |
| Scientific Title | Exploratory study of health-related functions of ONO-DA |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/13 11:14:15 |
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Basic information
Public title
Exploratory study of health-related functions of ONO-DA
Acronym
Exploratory study of health-related functions of ONO-DA
Scientific Title
Exploratory study of health-related functions of ONO-DA
Scientific Title:Acronym
Exploratory study of health-related functions of ONO-DA
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the health-related functions of daily intake of ONO-DA for four weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Transcript expression patterns
Key secondary outcomes
Hormonal balance, lipid metabolism, subjective assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of ONO-DA for four weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ohkubo |
Organization
ONO PHARMACEUTICAL CO., LTD.
Division name
Business Design, Business Promotion
Zip code
541-8564
Address
1-5, Dosho-machi 2-chome, Chuo-ku, Osaka
TEL
06-6263-2924
m.ohkubo@ono-pharma.com
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
メディカルステーションクリニック (東京都)、医療法人社団優恵会銀座よしえクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069387
