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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024315
Receipt No. 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

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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
Email 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
Email tomoyuki.fukasawa@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028007

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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