UMIN-CTR Clinical Trial

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 Satoshi Middle name Last name Sunabori
Organization	Kagome Co.Ltd.
Division name	Innovation division, Nature&Wellness research department
Zip code	3292762
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 Hiroki Middle name Last name Hayashi
Organization	Kagome Co.Ltd.
Division name	Innovation division, Nature&Wellness research department
Zip code	3292762
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	Kagome research ethics committee
Address	3-21-1 Nihonbashihamacho, Chuo, Tokyo
Tel	03-5623-8501
Email	Takuji_Hayakawa@kagome.co.jp

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	https://doi.org/10.3390/diseases9010004
Publication of results	Unpublished

Result
URL related to results and publications	https://doi.org/10.3390/diseases9010004
Number of participants that the trial has enrolled	26
Results	Cross-sectional analysis showed a significant positive correlation between Cutaneous Carotenoid Level (CCL) and vegetable intake. Vegetable juice consumption significantly increased CCL and the blood levels of alpha-carotene, beta-carotene, and lycopene.
Results date posted	2021 Year 07 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy adults
Participant flow	Subjects measure their skin everyday during experiment period. In the central 4 weeks of the experiment period, subjects drink a carton of vegetable juice everyday. Collection of blood has held 6 times during the period for blood carotenoid analysis.
Adverse events	NA
Outcome measures	Cutaneous carotenoid level, Blood carotenoid concentration, Dietary and living habit.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 Day
Date of IRB	2017 Year 07 Month 14 Day
Anticipated trial start date	2017 Year 09 Month 05 Day
Last follow-up date	2017 Year 12 Month 26 Day
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	2021 Year 07 Month 26 Day

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