UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016620 |
|---|---|
| Receipt number | 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 11:36:54 |
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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
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
Sakiko_Tanaka@kagome.co.jp
Sponsor or person
Institute
Kagome Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019298
