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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031550
Receipt No. R000036023
Scientific Title Effects of consumption of juice containing anthocyanin on sensitivity to cold
Date of disclosure of the study information 2018/03/02
Last modified on 2018/09/03

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Basic information
Public title Effects of consumption of juice containing anthocyanin on sensitivity to cold
Acronym Effect of anthocyanin on sensitivity to cold
Scientific Title Effects of consumption of juice containing anthocyanin on sensitivity to cold
Scientific Title:Acronym Effect of anthocyanin on sensitivity to cold
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of intervention with juice containing anthocyanin consumption on sensitivity to cold
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin surface temperature following the exposure to cold water stress
Key secondary outcomes Blood flow rate following the exposure to cold water stress

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Juice containing anthocyanin -> washout period -> Juice not containing anthocyanin -> washout period -> Mineral water
Interventions/Control_2 Juice not containing anthocyanin -> washout period -> Juice containing anthocyanin -> washout period-> Mineral water
Interventions/Control_3 Mineral water -> washout period -> Juice not containing anthocyanin -> washout period -> Juice containing anthocyanin
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
65 years-old >
Gender Female
Key inclusion criteria Healthy adult females with sensitivity to cold
Key exclusion criteria 1) Subjects who have alimentary allergy.
2) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period.
3) Subjects with vascular function disorder (arteriosclerosis obliterans, arteritis obliterans, connective tissue disease, diabetes mellitus)
4) Current smoker
5) Subjects who are judged unsuitable for this study by doctor because of participating in other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Aizawa
Organization Kagome CO.,LTD.
Division name Innovation Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Aizawa
Organization Kagome CO.,LTD.
Division name Innovation Division
Zip code
Address 17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL 0287-36-2935
Homepage URL
Email Koichi_Aizawa@kagome.co.jp

Sponsor
Institute Kagome CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 03 Month 02 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 03 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 07 Month 30 Day
Date analysis concluded
2018 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 02 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036023

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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