UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034393 |
|---|---|
| Receipt number | R000039211 |
| Scientific Title | Effect of continual intake of Satsuma mandarin on skin carotenoid level in human. |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/04/07 09:35:49 |
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Basic information
Public title
Effect of continual intake of Satsuma mandarin on skin carotenoid level in human.
Acronym
Effect of Satsuma mandarin on skin carotenoid level.
Scientific Title
Effect of continual intake of Satsuma mandarin on skin carotenoid level in human.
Scientific Title:Acronym
Effect of Satsuma mandarin on skin carotenoid level.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes of skin carotenoid level by intake of Satsuma mandarin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin carotenoid levels during the intake period and the post-intake period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects can't eat Satsuma mandarin during the intake period (4 weeks) and the post-intake period (4 weeks).
Interventions/Control_2
Subjects eat one Satsuma mandarin every day during the intake period (4 weeks) and can't eat any Satsuma mandarin during post-intake the period (4 weeks).
Interventions/Control_3
Subjects eat three Satsuma mandarins every day during the intake period (4 weeks) and can't eat any Satsuma mandarin during the post-intake period (4 weeks).
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
Healthy employee of KAGOME Co. Ltd. who agreed to participate in the examination.
Key exclusion criteria
1.Skin carotenoid level is 8.0 or higher.
2.Food allergy to the test food.
3.Fasting blood glucose is 100 mg / dL or more, or those who have had diagnosis of diabetes in the past.
4.Planning to become pregnant or lactating during the examination period.
5.Participate in other human tests involving intake of foods rich in carotenoid at the start of this study.
6.Who judged as inappropriate by the responsible investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suganuma |
Organization
KAGOME Co. Ltd.
Division name
Nature and wellness research department, Innovation division
Zip code
Address
17 Nishitomiyama, Nasushiobara, Tochigi
TEL
0287-36-2935
Hiroyuki_Suganuma@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
KAGOME Co. Ltd.
Division name
Nature and wellness research department, Innovation division
Zip code
Address
17 Nishitomiyama, Nasushiobara, Tochigi
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
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
| 2018 | Year | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 08 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039211
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
