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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019792
Receipt No. R000022863
Scientific Title A study for the effect of the powdered food on skin dry
Date of disclosure of the study information 2016/09/30
Last modified on 2017/08/11

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Basic information
Public title A study for the effect of the powdered food on skin dry
Acronym A study for the effect of the powdered food on skin dry
Scientific Title A study for the effect of the powdered food on skin dry
Scientific Title:Acronym A study for the effect of the powdered food on skin dry
Region
Japan

Condition
Condition Healthy female
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of the powdered food containing collagen peptide, ceramide, amino acid and glucosamine on skin dry.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Moisture Content of the Stratum Corneum
Key secondary outcomes Transepidermal water Loss
The skin evaluation by dermatologists
Improvement of symptoms

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 Institution is not considered as adjustment factor.
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of the powdered food containing collagen peptide, ceramide, amino acid, glucosamine 3g/day in 8 weeks
Interventions/Control_2 Ingestion of the placebo food 3g/day in 8 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
30 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1.Healthy female aged from 30 to 49 years old.
2.Persons who are aware of skin dryness.
3.Persons with water content in the stratum corneum =<50 and not severe dried skin.
Key exclusion criteria 1.Persons with a severe or progressive condition or symptom
2.Persons with a skin disease such as atopic dermatitis or eczema
3.Persons with food allergy
4.Persons with lactose intolerance
5.Persons who regularly used a drug , quasi drug, supplement or healthy food that affect this study.
6.Persons receiving special facial care
7.Persons who will get sunburned during the test period
8.Persons who are pregnant or who are planning or desiring pregnancy during the study period
9.Persons who are breastfeeding
10.In addition, persons who are judged inappropriate as the subject of this study by the investigator or sub-investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ochiai
Organization Meiji Company Limited
Division name Product Development Department
Zip code
Address 1-2-10 Shinsuna Koto-ku Tokyo
TEL 03-5653-0492
Email hiroshi.ochiai@meiji.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Kawate
Organization Meiji Company Limited
Division name Product Development Department
Zip code
Address 1-2-10 Shinsuna Koto-ku Tokyo
TEL 03-5653-0492
Homepage URL
Email yuuji.kawate@meiji.com

Sponsor
Institute Meiji Company Limited
Institute
Department

Funding Source
Organization Meiji Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 医療法人社団快晴会 しらゆり皮フ科・整形外科 新横浜スキンラボセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 1. Analysis of subjects including suspected of seasonal allergic rhinitis, stratum corneum water content in the active food group was significantly improved after 4 and 8 weeks-ingestion compared with before-ingestion, however there was no significant difference in the placebo food group. There was no significant difference between two groups.
2. Excluding subjects suspected of seasonal allergic rhinitis, the change of stratum corneum water content in 4 weeks-ingestion of active food group was significantly increased compared with placebo food group.
3. No adverse effects were observed in both 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
2015 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Jpn Pharmacol Ther 2017 45(7) 1167-78

Management information
Registered date
2015 Year 11 Month 15 Day
Last modified on
2017 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022863

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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