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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031176
Receipt No. R000035419
Scientific Title Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.
Date of disclosure of the study information 2018/03/01
Last modified on 2019/03/06

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Basic information
Public title Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.
Acronym Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.
Scientific Title Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.
Scientific Title:Acronym Evaluation of skin moisturizing effects by a vegetable and fruit juice intake.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate skin moisturizing effects by a vegetable and fruit juice intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stratum corneum water content at 4 and 8 weeks
Key secondary outcomes Skin elasticity, textures and wrinkles of skin, pigmentation, advanced glycation end products, and skin condition questionnaire at 4 and 8 weeks

Base
Study type Interventional

Study design
Basic design Parallel
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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food for 8 consecutive weeks
Interventions/Control_2 Intake of placebo for 8 consecutive 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 1) Japanese males and females aged 20 to 59 years old when agree to informed consent
2) Persons who have rough skins
3) Persons who have some age spots on face
4) Persons who have sagging skin
5) Persons who keep a stable lifestyle on dietary habit, especially meal time, and sleep
6) Persons who always eat breakfast every morning
7) Persons who are able to fill in all the necessary items on a daily questionnaire with intake diary and approximately 10 queries and another questionnaire about dietary survey of approximately 10 queries at designated days
Key exclusion criteria 1) Persons who are pregnant, could be pregnant in near future, or are lactating.
2) Persons who have menstrual disorder or have a significant change of some skin conditions by menstrual
3) Persons who might have an allergic symptoms on any components of test products.
4) Persons who are participating in other clinical trials
5) Persons who have a habit to take any more than 200ml vegetable juices three times a week
6) Persons who are routinely taking or applying any medicines for whitening and beautiful skin or anti-ultraviolet effect that might affect outcomes of this clinical trial
7) Persons who are routinely taking any health foods for whitening and beautiful skin or anti-ultraviolet effect that might affect outcomes of this clinical trial
8) Persons who have a past medical history of serious hepatopathy, renal problem, and cardiovascular disease
9) Persons who have a history of hepatitis or are affected
10) Persons who dislike vegetable juices, especially carrot one
11) Persons who have any skin damage or diseases such as wound and atopic dermatitis
12) Persons who have conducted a special facial treatment such as esthetic clinic, iontophoresis therapy, and peeling
13) Persons who have a plan to change their cosmetics used during this clinical trial
14) Persons who work night or irregular shifts
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 81-3-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Azusa Kouno
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 81-3-5408-1555
Homepage URL
Email a_kouno@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization ITO EN, 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
Address
Tel
Email

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
2018 Year 03 Month 01 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
There was no significant difference between groups.
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
2017 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 06 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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