UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062853 |
|---|---|
| Receipt number | R000071955 |
| Scientific Title | Exploratory study on multifaceted health values of test food |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 10:34:14 |
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Basic information
Public title
Exploratory study on multifaceted health values of test food
Acronym
Exploratory study on multifaceted health values of test food
Scientific Title
Exploratory study on multifaceted health values of test food
Scientific Title:Acronym
Exploratory study on multifaceted health values of test food
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 4-week continuous intake of test food on skin moisture, bowel movements, fatigue, and diet-related urinary markers (such as indoxyl sulfate) in men and women aged 22 to 64 years old. The purpose is to identify optimal outcomes for subsequent confirmatory randomized controlled trials through this exploratory study and contribute to formulating market strategies that maximize the health value of test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (Visual Analog Scale) for skin dryness at baseline (before intake), and after 1, 2, 3, and 4 weeks of intake.
Key secondary outcomes
1. Skin moisture (measured by MS2-MO) at baseline, and after 1, 2, 3, and 4 weeks of intake.
2. VAS for fatigue (physical fatigue, mental fatigue, total fatigue) at baseline, and after 1, 2, 3, and 4 weeks of intake.
3. Constipation Assessment Scale (CAS) at baseline and after 4 weeks of intake.
4. Daily defecation questionnaire (stool volume, stool form) during the intake period.
5. Urinalysis (indoxyl sulfate) at baseline and after 4 weeks of intake.
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 intake of 15 mL (once a day) of test food for 4 weeks (dilution with water etc. is permitted, no specified timing).
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons who received a sufficient explanation of the purpose and contents of the study, applied voluntarily with sufficient understanding, and agreed to participate in the study with written consent.
2) Healthy Japanese male and female persons who are 22 years old or more and under 65 years old at the time of obtaining consent.
Key exclusion criteria
1) Persons who have chronic illness and receive medication, or have a serious disease history (except those judged by the supervising physician or principal investigator to have no issues).
2) Persons who have skin diseases (such as atopic dermatitis).
3) Persons who easily develop symptoms such as diarrhea or abdominal pain (weak gastrointestinal tract).
4) Persons who have food allergies to the test food.
5) Persons who are participating in other clinical studies.
6) Persons who are pregnant, may be pregnant, or are breastfeeding.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Odawara |
Organization
Kewpie Jyozo Co., Ltd.
Division name
Research Group
Zip code
182-0002
Address
Sengawa Kewport, 2-5-7, Sengawacho, Chofu-shi, Tokyo, JAPAN
TEL
03-5384-7670
makoto_odawara@kewpie-jyozo.co.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Kato |
Organization
Kewpie Jyozo Co., Ltd.
Division name
Research Group
Zip code
306-0315
Address
Kotesashi 1800, Goka-machi, Sashima-gun, Ibaraki JAPAN
TEL
0280-84-2221
Homepage URL
yukiko_kato@kewpie-jyozo.co.jp
Sponsor or person
Institute
Kewpie Jyozo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Jyozo 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 09 | Month | 09 | 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 | 08 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 11 | 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
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071955
