UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034393
Receipt No. 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 2018/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
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

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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 04 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
2018 Year 10 Month 05 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.