UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057322 |
|---|---|
| Receipt number | R000065522 |
| Scientific Title | Mechanism of Action Analysis of Plant-Derived Processed Food Intake |
| Date of disclosure of the study information | 2025/03/21 |
| Last modified on | 2025/09/17 14:22:56 |
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Basic information
Public title
Mechanism of Action Analysis of Food Intake
Acronym
Mechanism of Action Analysis of Food Intake
Scientific Title
Mechanism of Action Analysis of Plant-Derived Processed Food Intake
Scientific Title:Acronym
Mechanism of Action Analysis of Food Intake
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the variations in biological components due to the continuous intake of plant-derived processed foods and validate the mechanisms of allergy suppression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Redness of the face
Key secondary outcomes
-Skin color (L value, a value, b value, etc.)
-Blood Allergy Markers
-Blood Test and Analysis
-Sebum Analysis Data
-Fecal Microbiota Analysis Data
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of active food once a day for 4 weeks.
Interventions/Control_2
Intake of placebo food once a day for 4 weeks.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese men and women aged 20 to 59 years old
Key exclusion criteria
1. Individuals who do not have any awareness of allergy-related symptoms.
2. Individuals who may exhibit allergic symptoms in response to food.
3. Individuals with skin diseases, liver, kidney, or heart diseases, respiratory disorders, endocrine disorders, metabolic disorders, neurological disorders, consciousness disorders, diabetes, or other medical conditions.
4. Individuals who have undergone surgery due to illness or injury within the past two months.
5. Individuals who have experienced discomfort or deterioration in health due to blood sampling in the past.
6. Individuals who have donated blood exceeding 200 mL within one month prior to the start of the trial, or over 400 mL within three months prior to the trial.
7. Individuals receiving pharmacological treatment.
8. Individuals with a habit of continuously consuming flaxseed oil, perilla oil, or DHA|EPA supplements, or who plan to do so during the study period.
9. Individuals whose daily alcohol consumption exceeds an average of 60 g|day.
10. Individuals engaged in sun exposure activities or who plan to participate in such activities during the study period.
11. Individuals who have experienced a weight change of 3.0 kg or more in the month prior to the study participation.
12. Individuals with a BMI of less than 18.5 kg|m2 or 30.0 kg|m2 or greater.
13. Individuals who have plans for long-term business trips.
14. Individuals with a smoking habit.
15. Individuals who will undergo aesthetic or medical beauty treatments on the study areas.
16. Individuals who intend to use skincare products targeting skin roughness on the study areas.
17. Individuals who have been infected with infectious diseases.
18. Individuals who are pregnant or may become pregnant.
19. Individuals who are not on a day shift.
20. Individuals who plan to participate in other clinical studies.
21. Individuals deemed unsuitable for participation in the study by the principal investigator or research director for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Fukagawa |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3297-0978
fukagawa.satoko@kao.com
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Shimotoyodome |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3297-0998
Homepage URL
shimotoyodome.yoshie@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2025 | Year | 03 | Month | 21 | 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
20
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 | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065522
