UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031176 |
|---|---|
| Receipt number | 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 10:01:45 |
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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
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
a_kouno@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035419
