UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031550 |
|---|---|
| Receipt number | 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 10:43:38 |
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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
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
Koichi_Aizawa@kagome.co.jp
Sponsor or person
Institute
Kagome CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036023
