UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061474 |
|---|---|
| Receipt number | R000070343 |
| Scientific Title | Safety Evaluation of a 12-Week Continuous Intake of an Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study) |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 15:44:03 |
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Basic information
Public title
Safety Evaluation Study of 12-Week Continuous Intake of Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study)
Acronym
A 12-week safety study of food containing egg-derived ingredients in healthy adults
Scientific Title
Safety Evaluation of a 12-Week Continuous Intake of an Egg-Derived Ingredient-Containing Food: A Single-Arm, Pre-Post Comparison Study (Open-Label Study)
Scientific Title:Acronym
A 12-week safety study of food containing egg-derived ingredients in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the safety and exploratory efficacy of a 12-week continuous intake of an egg-derived ingredient-containing food by assessing various blood metabolite markers, clinical laboratory parameters (hematology, blood chemistry, etc.), and gut microbiota in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Clinical laboratory parameters (hematology, blood chemistry, and urinalysis) for safety assessment.
2.Changes from baseline in specific blood metabolites and gut microbiota composition.
3.Evaluation of dietary habits, nutrient intake, and lifestyle patterns using validated questionnaires.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will consume 6 tablets of the test food (containing a specific egg-derived ingredient) once daily at breakfast with water for 12 consecutive weeks (84 days).
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese male and female adults.
Subjects who have provided voluntary written informed consent after receiving a thorough explanation of the study and fully understanding its nature.
Subjects judged to be suitable for the study by the investigator or sub-investigator.
Key exclusion criteria
Food Allergies: Subjects with known food allergies to the ingredients of the test food (e.g., eggs, soybeans).
Medical History: Subjects with serious heart, liver, renal, or gastrointestinal diseases, or a history of such conditions. This includes subjects with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2, calculated from recent health check-up results (creatinine levels) provided by the subject.
Medications: Subjects habitually taking medications that may affect blood parameters or gut microbiota composition (e.g., antibiotics, medications for dyslipidemia, or diabetes).
Non-compliance: Subjects judged to have difficulty adhering to the study requirements (e.g., 12-week continuous intake of the test food, consumption of the standardized meal, and the prescribed fasting period prior to measurements).
Hormonal Preparations: Females habitually using hormonal preparations, such as oral contraceptives.
Investigator's Judgment: Others judged to be unsuitable for participation in the study by the principal investigator or the physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Matsuoka |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
ryosuke_matsuoka@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yui/ Wei |
| Middle name | |
| Last name | Ou/Wang |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
yui_ou@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
Shiba Palace Clinic Ethics Committee
Address
DaiwaA Hamamatsucho Building 3F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1555
shiba_palace@s-palace-clinic.com
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 | 05 | Month | 07 | 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 | 03 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 16 | 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 | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070343
