UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062092 |
|---|---|
| Receipt number | R000071044 |
| Scientific Title | A Long-Term Study on Fresh Food Intake in Healthy Adults : Open-label study |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/06/29 17:12:07 |
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Basic information
Public title
A Long-Term Study on Fresh Food Intake in Healthy Adults
Acronym
A Long-Term Study on Fresh Food Intake in Healthy Adults
Scientific Title
A Long-Term Study on Fresh Food Intake in Healthy Adults
: Open-label study
Scientific Title:Acronym
A Long-Term Study on Fresh Food Intake in Healthy Adults
: Open-label study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food intake on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain waves during sleep
OSA sleep inventory MA version
Diet Survey
Survey on Subjective Perceptions of Fatigue and Physical Condition
Key secondary outcomes
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
Ingestion of test food for 4 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 64
(2) Subjects with a PSQI-J score of 5 or higher
(3) Subjects who do not consume enough vegetables in their daily diet
Key exclusion criteria
(1) Subjects with diseases currently being treated
(2) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs)
(3) Subjects living with children under the age of 5
(4) Subjects who are participating in or will participate in other clinical trials at the start of this study
(5) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Mizokami |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
0353847768
mitsuhiro_mizokami@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Ozawa |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
0353847768
Homepage URL
natsuki_ozawa@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6809-5220
mterashima@miura-cl.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
| 2026 | Year | 06 | Month | 30 | 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
10
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
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071044
