UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056478 |
|---|---|
| Receipt number | R000064509 |
| Scientific Title | Exploratory research on the functionality of test food for health |
| Date of disclosure of the study information | 2024/12/22 |
| Last modified on | 2025/12/17 09:14:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory research on the functionality of test food for health
Acronym
Exploratory research on the functionality of test food for health
Scientific Title
Exploratory research on the functionality of test food for health
Scientific Title:Acronym
Exploratory research on the functionality of test food for health
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Proteomic analysis of the stratum corneum will be utilized to elucidate the biological response at the molecular level to sustained consumption of the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum proteome
Key secondary outcomes
Skin properties (stratum corneum water content, sebum content, transepidermal water loss, melanin index, erythema index, skin color, spots, brown spots, red spots, redness, pores, porphyrins, texture, latent spots, wrinkles)
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
After 28 days of pre-observation, the test food will be consumed once daily for 56-61 days continuously.
Interventions/Control_2
After 28 days of pre-observation, no test food will be consumed for 56-61 days.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1. Individuals with current or previous diagnoses of psychiatric disorders, chronic fatigue syndrome, or sleep disorders.
2. Individuals with current or previous diagnoses of diabetes, hepatic, renal, cardiac, or respiratory disorders, conditions affecting adrenal cortical hormone secretion, or other metabolic diseases.
3. Individuals with cutaneous scarring, inflammation, or other dermatological conditions (e.g., atopic dermatitis, acne) at the measurement site.
4. Individuals seeking dermatological consultation due to cutaneous conditions or discomfort at the measurement site.
5. Individuals undergoing dermatological pharmacotherapy at the measurement site.
6. Individuals who have undergone dermatological cosmetic procedures at the measurement site within four weeks prior to the commencement of the study or those who intend to undergo such procedures during the study period.
7. Individuals who have a habit of washing their face and body with strong irritation to the measurement site, such as using nylon towels.
8. Individuals who may use medications for allergic manifestations of the skin (e.g., erythema, pruritus) due to hay fever or similar conditions during the study period.
9. Individuals with allergies to the test food.
10. Pregnant or possibly pregnant.
11. Lactating mothers.
12. Individuals deemed unsuitable for participation in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Gomi |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo, Japan
TEL
042-577-8960
atsushi-gomi@yakult.co.jp
Public contact
Name of contact person
| 1st name | Koh |
| Middle name | |
| Last name | Maki |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi, Tokyo, Japan
TEL
042-577-8960
Homepage URL
ko-maki@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo, Japan
Tel
03-6452-2712
nakajima.megumi888@eps.co.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
| 2024 | Year | 12 | Month | 22 | 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
29
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064509
