UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039342 |
|---|---|
| Receipt number | R000044872 |
| Scientific Title | The effects of food ingestion on face skin |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2020/08/03 09:39:10 |
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Basic information
Public title
The effects of food ingestion on face skin
Acronym
The effects of food ingestion on face skin
Scientific Title
The effects of food ingestion on face skin
Scientific Title:Acronym
The effects of food ingestion on face skin
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food ingestion on face skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Noticeable pores (number)
Key secondary outcomes
Wrinkles (number),Skin color tone, Skin clearness, Skin lightning, Skin elasticity, Sagging, Resting liquid volume, Height, body weight, BMI, Intake rate of test food or placebo food
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food ( 6 weeks intake)
Interventions/Control_2
Placebo food (6 weeks 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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Females from 20 to 60 years of age
(2) Healthy females who do not eat much test food in a day
(3) Subjects giving written informed consent
(4) No skin disease such as atopic dermatitis rash
Key exclusion criteria
(1) Individuals having symptoms that affect test food ingestion
(2) Individuals taking medications that may affect results
(3)Individuals who may develop allergies in connection with the test
(4) Individuals who have the will of pregnancy or are breast-feeding during the study period
(5)Individuals who find it difficult to continue test food ingestion during the period
(6)Individuals deemed inappropriate by the study director to participate in the study
(7) Individuals with skin problems (wounds that hinder examination) or diseases (such as atopic dermatitis rash)
(8) Individuals with serious diseases such as diabetes, liver disease, and heart disease
(9) Individuals who regularly take medications that require a doctor's prescription
(10) Individuals who plan to tan in outdoor sports * from the first month of the test until the end of the test
(11) Individuals who cannot use the same skin care and cosmetics during the test period
(12) Individuals undergoing treatments such as at a beauty care institution or esthetic that may affect the test results during the test period
(13) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
*:Sunburn within daily life is allowed.
Target sample size
30
Research contact person
Name of lead principal investigator
| 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
048-837-0187
oosawa_kenji@lotte.co.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Matsui |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Food Material Development Section
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
Homepage URL
matsui_misaki@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
| 2020 | Year | 02 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044872
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