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

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 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


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

Value
https://center6.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