UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058518 |
|---|---|
| Receipt number | R000066913 |
| Scientific Title | A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males. |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/18 15:47:04 |
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Basic information
Public title
A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males.
Acronym
A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males.
Scientific Title
A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males.
Scientific Title:Acronym
A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of a test food on blood biomarkers and sensory indicators in healthy adult males.
In addition, measuring blood concentrations after intake of a test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein concentration in red blood cells
Key secondary outcomes
Body perception
Plasma concentration of chemical compounds
Urinary excretion of chemical compounds
Vertical jump
Life skills scale for adolescents and adults
Aging males' symptoms score
International index of erectile function-5
Perceived stress scale-10
General health questionaire-12
Free-response questionnaire
Activity level
Quality of sleep
Physical measurement
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 | Behavior,custom |
Interventions/Control_1
Intake the test food once a day 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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Those who provided written informed consent to participate in the study.
2)Healthy Japanese males aged 20-69 years at the time of providing informed consent to participate in the study.
3)Those who are able to visit the clinic on the designated examination dates and undergo the required tests.
Key exclusion criteria
1)Individuals whose clinical laboratory values deviate significantly from the reference range and who are deemed ineligible for the study by the principal investigator.
2)Individuals with a serious medical history involving major organs or systems, or those currently undergoing treatment, who are deemed ineligible for the study by the principal investigator.
3)Individuals taking antihypertensive medication.
4)Individuals with implanted medical electrical devices such as pacemakers.
5)Individuals with a current or past history of drug or food allergies.
6)Individuals otherwise deemed unsuitable as study subjects by the principal investigator or study coordinator.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga
TEL
0952-52-1522
Mizokami.Tsubasa@otsuka.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga
TEL
0952-52-1522
Homepage URL
Mizokami.Tsubasa@otsuka.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishukai Clinic, Seishukai Medical corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku-ku, Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 22 | 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 | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066913
