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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028320
Receipt No. R000032414
Scientific Title The influence of vegetable juice intake on blood and skin carotenoid levels.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/01/22

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Basic information
Public title The influence of vegetable juice intake on blood and skin carotenoid levels.
Acronym The influence of vegetable juice intake on blood and skin carotenoid levels.
Scientific Title The influence of vegetable juice intake on blood and skin carotenoid levels.
Scientific Title:Acronym The influence of vegetable juice intake on blood and skin carotenoid levels.
Region
Japan

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

Objectives
Narrative objectives1 Clarify the correlation among vegetable intake and blood carotenoid concentration and skin carotenoid level.
Basic objectives2 Others
Basic objectives -Others Vegetable intake, Blood carotenoid concentration and Skin carotenoid level.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Vegetable intake(after pre-treatment observation period, after treatment observation period, after post-treatment observation period), blood carotenoid concentration(before and after pre-treatment observation period, 2weeks and 4weeks later of treatment observation period, 2weeks and 4weeks later of post-treatment observation period), skin carotenoid level(before and after pre-treatment observation period, 2weeks and 4weeks later of treatment observation period, 2weeks and 4weeks later of post-treatment observation period)
Key secondary outcomes Skin carotenoid level(every measuring day), blood triglyceride concentration(before and after pre-treatment observation period, 2weeks and 4weeks later of treatment observation period, 2weeks and 4weeks later of post-treatment observation period), blood total cholesterol concentration(before and after pre-treatment observation period, 2weeks and 4weeks later of treatment observation period, 2weeks and 4weeks later of post-treatment observation period)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 In 4 weeks pre-treatment observation period, subjects don't change their dietary habits. In 4 weeks treatment observation period, subject takes 200mL of vegetable juice everyday. In 4 weeks post-treatment observation period, subjects don't change their dietary habits.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Those who are healthy adult men and women and have obtained informed consent
Key exclusion criteria 1.Those who routinely take vegetable juices equal to or more than the same amount (200 mL) as the test food.
2.Food allergy to test food.
3.Those who of alcohol hypersensitivity which makes alcohol disinfection difficult.
4.Those who planning to become pregnant or lactating during the examination period.
5.Those who participate in other human tests involving intake of foods rich in carotenoid at the start of this study.
6.Those who judged that the investigator's doctor is inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Sunabori
Organization Kagome Co.Ltd.
Division name Innovation division, Nature&Wellness research department
Zip code
Address Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL 0287-36-2935
Email Satoshi_Sunabori@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Kagome Co.Ltd.
Division name Innovation division, Nature&Wellness research department
Zip code
Address Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL 0287-36-2935
Homepage URL
Email Hiroki_Hayashi@kagome.co.jp

Sponsor
Institute Kagome Co.Ltd.
Institute
Department

Funding Source
Organization Kagome 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 カゴメ株式会社イノベーション本部(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 05 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
2017 Year 07 Month 21 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032414

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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