UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059045 |
|---|---|
| Receipt number | R000067540 |
| Scientific Title | Effects of test food intake on the health status of healthy subjects |
| Date of disclosure of the study information | 2025/09/10 |
| Last modified on | 2025/09/10 14:52:27 |
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Basic information
Public title
Effects of test food intake on the health status of healthy subjects
Acronym
Effects of test food intake on the health status of healthy subjects
Scientific Title
Effects of test food intake on the health status of healthy subjects
Scientific Title:Acronym
Effects of test food intake on the health status of healthy subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test food consumption on sleep, body weight, changes in physical condition, and overall health status in Japanese men and women aged 18 to 27 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep quality and duration, body weight, blood glucose levels, body composition, physical activity, and mental health status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test food #1 every weekday evening
Interventions/Control_2
Intake of the test food #2 every weekday evening
Interventions/Control_3
Intake of control food every weekday evening
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
| 18 | years-old | <= |
Age-upper limit
| 27 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 years or older and under 27 years, with no health problems.
2.Individuals who have received a full explanation of the study, sufficiently understood the contents, and voluntarily provided informed consent to participate.
Key exclusion criteria
1.Individuals with any current medical conditions under treatment.
2.Individuals who use health foods and medicines that contain ingredients that affect the trial.
3.Any other individuals deemed inappropriate as study participants by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kaneko |
Organization
Meiji University
Division name
School of Agriculture
Zip code
214-8571
Address
1-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa, Japan
TEL
044-934-7838
kanekok@meiji.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kaneko |
Organization
Meiji University
Division name
School of Agriculture
Zip code
214-8571
Address
1-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa, Japan
TEL
044-934-7838
Homepage URL
kanekok@meiji.ac.jp
Sponsor or person
Institute
Meiji University
Institute
Department
Personal name
Funding Source
Organization
Meiji University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Research Experiments, Meiji University
Address
1-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa 214-8571, Japan
Tel
044-934-7720
osri@mics.meiji.ac.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 | 09 | Month | 10 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067540
