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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016620
Receipt No. R000019298
Scientific Title Effects of continual consumption of mixed vegetable and fruit juice on skin condition
Date of disclosure of the study information 2015/02/24
Last modified on 2015/08/07

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Basic information
Public title Effects of continual consumption of mixed vegetable and fruit juice on skin condition
Acronym Effects of continual consumption of mixed vegetable and fruit juice on skin condition
Scientific Title Effects of continual consumption of mixed vegetable and fruit juice on skin condition
Scientific Title:Acronym Effects of continual consumption of mixed vegetable and fruit juice on skin condition
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of intervention with mixed vegetable and fruit juice consumption on skin condition of Japanese women
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin image analysis (UV spots, brown spots)
Mean cell area
Skin replica analysis (skin texture)
Microscope analysis (skin texture)
Skin color (L/a value)
Serum beta-carotene
Serum alpha-carotene
Serum beta-cryptoxanthin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) 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 Test material: mixed vegetable and fruit juice
Duration: 8 weeks
Dose: 200ml/day
Interventions/Control_2 Test material: water
Duration: 8 weeks
Dose: 200ml/day
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
55 years-old >=
Gender Female
Key inclusion criteria People who meet the following conditions will be required.
1) Who has no habit of drinking vegetable juice.
2) Who has mild to moderate dry skin.
3) Whose water content of stratum corneum on the right cheek is relatively low.
4) Whose score of UV spots is relatively high.
5) Who can provide written informed consents by her own free will.
Key exclusion criteria People who meet any of the following conditions will be excluded.
1) Who is a patient of atopic dermatitis, contact dermatitis or dermal hypersensitivity.
2) Who has drug or food allergies.
3) Who has a pollen allergy and takes medicine.
4) Who cannot drink vegetable juice or mixed vegetable and fruit juice.
5) Who has a marked surgical history of digestive system or has breathing problems or heart diseases.
6) Who has a smoking habit.
7) Who is addicted to alcohol or has an extremely irregular dietary habit.
8) Who is receiving hormonal replacement therapy.
9) Who is extremely suntanned or spends long time outdoors.
10) Who takes special care of facial skin (facial massager, going to facial spa, chemical peeling, laser therapy, and so on).
11) Who takes drugs, quasi-drugs, dietary supplements, health foods, or something other which possibly have effects on this study.
12) Who is planning to go abroad or go to the beach during the study period.
13) Who is pregnant or breastfeeding, or desires to get pregnant during the study period.
14) Who is judged unsuitable for this study by principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Sunabori
Organization Kagome Co., Ltd.
Division name Research & Development Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Email Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Tanaka
Organization Kagome Co., Ltd.
Division name Research & Development Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Homepage URL
Email Sakiko_Tanaka@kagome.co.jp

Sponsor
Institute Kagome Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Exam Co., Ltd.
Medical Corporation Kojinkai
SPC Co., Ltd.
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
2015 Year 02 Month 24 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
2015 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 24 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
2015 Year 02 Month 24 Day
Last modified on
2015 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019298

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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