UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049134 |
|---|---|
| Receipt number | R000055874 |
| Scientific Title | Evaluation of the effect of intake of test food on improvement of vascular function |
| Date of disclosure of the study information | 2022/10/06 |
| Last modified on | 2023/04/07 11:40:18 |
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Basic information
Public title
Evaluation of the effect of intake of test food on improvement of vascular function
Acronym
Evaluation of the effect of intake of test food on improvement of vascular function
Scientific Title
Evaluation of the effect of intake of test food on improvement of vascular function
Scientific Title:Acronym
Evaluation of the effect of intake of test food on improvement of vascular function
Region
| Japan |
Condition
Condition
Healthy adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of intake of test food on improvement of vascular function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Status of capillary
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of the test foods (12 weeks)
Interventions/Control_2
Intake of placebo foods (12 weeks)
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 40 to 65 years.
2) Person who do not habitually consume large amounts of pomegranates, berries, nuts, etc. (not have extreme preferences)
Key exclusion criteria
1) Persons who have excessive alcohol intake more than approximately 500ml/day of beer equivalent or habit of heavy drink of alcohol.
2) Persons who use of health food product, such as food for specified health use, food with function claims, and dietary supplement.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ukawa |
Organization
DAICEL CORPORATION
Division name
Healthcare SBU
Zip code
108-8230
Address
2-18-1, Konan, Minato-ku, Tokyo
TEL
03-6711-8213
yi_ukawa@jp.daicel.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ukawa |
Organization
DAICEL CORPORATION
Division name
Healthcare SBU
Zip code
108-8230
Address
2-18-1, Konan, Minato-ku, Tokyo
TEL
03-6711-8213
Homepage URL
yi_ukawa@jp.daicel.com
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
DAICEL CORPORATION
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
Shiba Palace Clinic
Address
1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2022 | Year | 10 | Month | 06 | 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
32
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under preparation for publish
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
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | 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=R000055874
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
