UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024315 |
|---|---|
| Receipt number | R000028007 |
| Scientific Title | Effect of beauty foods on dry skin conditions in Japanese women - A randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2016/11/04 |
| Last modified on | 2017/04/06 11:40:04 |
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Basic information
Public title
Effect of beauty foods on dry skin conditions in Japanese women - A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Effect of beauty foods on dry skin conditions in Japanese women
Scientific Title
Effect of beauty foods on dry skin conditions in Japanese women - A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Effect of beauty foods on dry skin conditions in Japanese women
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement of dry skin conditions by the intake of beauty foods
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
moisture content of the stratum corneum
skin dryness symptoms in cheek
Key secondary outcomes
transepidermal water loss
skin dryness symptoms in forearm
Skindex-16
awareness questionnaire for skin
awareness questionnaire for fecal condition
serum thymus and activation- regulated chemokine (TARC)
defecation frequency
defecation days
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Beauty foods (once a day for 4 weeks)
Interventions/Control_2
Placebo (once a day for 4 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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Subjects giving written informed consent
2) Females from 20 to 49 years of age
Subjects with symptoms of skin dryness
Subjects with a tendency for constipation at two to four times defecation per week
Key exclusion criteria
1)Subjects who have chronic diseases and administer treatments and medications
2)Subjects with apparent pigmentation, inflammation, and other diseases in the test area
3)Subjects with milk or gelatin allergy
4)Subjects with lactose intolerance
5)Subjects who habitually consume yogurt or fermented milk drink more than twice a week in 3 months
6) Subjects who routinely use pharmaceuticals, quasi-drugs, dietary supplement, food for specified health uses, foods with function claims which influence bowel movement or skin dryness in 3 months
7)Subjects who participated in other clinical trials within a month or plan to participate other clinical trials during this study period
8)Subjects who are in pregnancy, or willing to be pregnant during this study period
9)Subjects who is breast-feeding
10)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketo Yamaji |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories , R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa
TEL
0465-37-3652
taketo.yamaji@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fukasawa |
Organization
Meiji Co., Ltd.
Division name
Food Science Research Laboratories , R&D Division
Zip code
Address
540 Naruda, Odawara, Kanagawa
TEL
0465-37-3652
Homepage URL
tomoyuki.fukasawa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
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
| 2016 | Year | 11 | Month | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 04 | 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
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
