UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048765 |
|---|---|
| Receipt number | R000055557 |
| Scientific Title | Investigation of facial condition and diet effect by food intake |
| Date of disclosure of the study information | 2022/08/30 |
| Last modified on | 2023/03/01 14:08:01 |
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Basic information
Public title
Investigation of facial condition and diet effect by food intake
Acronym
Investigation of facial condition and diet effect by food intake
Scientific Title
Investigation of facial condition and diet effect by food intake
Scientific Title:Acronym
Investigation of facial condition and diet effect by food intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of facial condition and diet effect by food intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Skin viscoelasticity
*Number of prominent pores, wrinkles and coloration
*Size of the face, sagging of the face
*Angle of the facial line
*Abdominal circumference
*Height, weight, BMI
*Gum chewing diary
*Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test food
Interventions/Control_2
No intake
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Healthy women in their 20s-40s
(2) Those who can eat test foods (for preference)
(3) Those who have received sufficient explanation of the purpose and content of the study, have the ability to consent, have voluntarily volunteered to participate with a good understanding, and have agreed to participate in this study in writing
(4) Those with no evidence of skin diseases such as atopic dermatitis skin rash
Key exclusion criteria
(1) Those who have any symptoms that may affect test food intake
(2) Those who take medications that could potentially affect the outcome
(3) Those who may develop allergies related to the study
(4) Those who plan to become pregnant or breastfeed during the study period
(5) Those who find it difficult to consume the test food during the period
(6) Those who are judged by the study representative to be inappropriate to participate in this study
(7) Those who have skin problems (e.g., wounds that interfere with examination) or diseases (e.g., skin rashes from atopic dermatitis).
(8) Those who plan to tan in outdoor sports or other activities from the start of the examination to the end of the examination (tanning within the scope of daily life is not a problem)
(9) Those who are unable to use the same skin care or cosmetic products without changing them during the study period
(10) Those who undergo any treatment at cosmetic medical institutions or esthetic clinics during the examination period that may affect the results of the examination
(11) Other subjects deemed unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Okabayashi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
okabayashi_kazuto@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Osawa |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Kamukoto Research Department
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0744
Homepage URL
oosawa_kenji@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
| 2022 | Year | 08 | 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
56
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
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 08 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055557
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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