UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026365 |
|---|---|
| Receipt number | R000030297 |
| Scientific Title | Clinical Evaluation of intake of juice with anthocyanin on blood flow and flow mediated dilatation. |
| Date of disclosure of the study information | 2017/03/02 |
| Last modified on | 2018/03/02 13:56:52 |
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Basic information
Public title
Clinical Evaluation of intake of juice with anthocyanin on blood flow and flow mediated dilatation.
Acronym
Effect of juice with anthocyanin on blood flow and flow mediated dilatation.
Scientific Title
Clinical Evaluation of intake of juice with anthocyanin on blood flow and flow mediated dilatation.
Scientific Title:Acronym
Effect of juice with anthocyanin on blood flow and flow mediated dilatation.
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 alteration of blood flow and flow mediated dilatation after ingestion of juice with anthocyanin or mineral water in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of blood flow rate for 30 minutes after ingestion of experimental drink.
Change of FMD at 0, 2 and 4 hours after ingestion of experimental drink.
Key secondary outcomes
Change of skin surface temperature for 30 minutes after ingestion of experimental drink.
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Juice with anthocyanin 530 g
Interventions/Control_2
Mineral water 530 g
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults Subjects
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 who are judged unsuitable for this study by doctor because of participating in other intervention trials.
4) 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
| 2017 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 02 | 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
| 2017 | Year | 03 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030297
