UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059997 |
|---|---|
| Receipt number | R000068567 |
| Scientific Title | A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study- |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 15:05:17 |
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Basic information
Public title
A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study-
Acronym
A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study-
Scientific Title
A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study-
Scientific Title:Acronym
A Study for Evaluating the Effects of test food Intake on Hormones and Related Parameters - single-arm open-label study-
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of consuming test food on hormonal and related paraments over a 12-week period. In addition, the long-term safety of the test food will be assessed during the same time frame.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Testosterone levels
Key secondary outcomes
1) PSQI-J
2) JAMQ
3) Likert-Type Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily consumption of the test food over 12 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) Healthy Japanese males aged 40 years old or older but under 65 at the time of consent.
(2) Individuals who report subjective symptoms such as fatigue, lethargy, lack of energy, or decreased libido.
(3) Individuals who have results from a health examination conducted within the past year and show no abnormalities requiring treatment.
(4) Individuals who have received sufficient explanation about the study and have signed the informed consent form prior to the study initiation.
Key exclusion criteria
(1) Individuals who are currently undergoing treatment for, or have a history of, malignant tumors, heart failure, or myocardial infarction.
(2) Individuals currently receiving treatment for, or with a history of, the following conditions:
[1] Arrhythmia, liver dysfunction, renal impairment, cerebrovascular disease, thyroid disorders, rheumatoid arthritis, diabetes, dyslipidemia, hypertension, or other chronic illnesses.
[2] Conditions requiring hormone therapy.
(3) Individuals currently undergoing treatment for, or with a history of, drug or alcohol dependence.
(4) Individuals diagnosed with male infertility.
(5) Individuals with mental disorders, depressive symptoms, or currently receiving treatment for such conditions.
(6) Individuals with food allergies or those who may have allergic reaction to test food.
(7) Individuals who regularly use prescription drugs or quasi-drugs that may affect the study outcomes and are unable to discontinue their use during the study period.
(8) Individuals who regularly consume health foods that may affect the study outcomes and are unable to discontinue their use during the study period.
(9) Individuals who consume excessive amounts of alcohol.
(10) Individuals with heavy smoking habits.
(11) Individuals unable to abstain from alcohol and smoking from the day before each visit until the end of the examination.
(12) Individuals who may be unable to maintain their usual lifestyle.
(13) Individuals with extremely irregular lifestyle habits, such as night shift workers.
(14) Individuals planning to travel abroad during the study period.
(15) Individuals who participated in another clinical trial within one month prior to the date of consent, or plan to participate in another clinical trial during the study period.
(16) Individuals deemed inappropriate for participation by the principal investigator.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Tomita |
Organization
Yurala Co., Ltd.
Division name
CEO
Zip code
105-0001
Address
1-23-2, Toranomon, Minato-ku, Tokyo 105-0001, Japan
TEL
03-6777-7789
tomita@yurala.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Yurala Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Otaku, Tokyo, 144-0043, Japan
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 05 | 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
| 2025 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068567
