UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028320 |
|---|---|
| Receipt number | 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 | 2021/07/26 14:10:59 |
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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 | 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
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
Hiroki_Hayashi@kagome.co.jp
Sponsor or person
Institute
Kagome Co.Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032414
