UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030619 |
|---|---|
| Receipt number | R000034967 |
| Scientific Title | Investigation on change with time of blood polyphenol concentration after its oral administration |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2017/12/28 16:00:09 |
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Basic information
Public title
Investigation on change with time of blood polyphenol concentration after its oral administration
Acronym
Investigation on change with time of blood polyphenol concentration after its oral administration
Scientific Title
Investigation on change with time of blood polyphenol concentration after its oral administration
Scientific Title:Acronym
Investigation on change with time of blood polyphenol concentration after its oral administration
Region
| Japan |
Condition
Condition
Normal healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation on change with time of blood polyphenol concentration after its oral administration
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of serum polyphenol
Key secondary outcomes
serum uric acid, creatinine, LDL cholesterol level, HDL cholesterol level, neutral fat, total cholesterol level, blood glucose level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of plant polyphenol
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Persons who have full ethical and regulatory approval and themselves and parental guardian give written informed consent
2.Healthy men and women who have serum uric acid value less than 8.0 mg / dL, and have never suffered a gout symptom
3.Healthy Japanese over 20 years old
Key exclusion criteria
1.Persons receiving medications such as uric acid levels, hypertension, diabetes, etc.
2.Persons who are allergic to the test food
3.Pregnancy, breast-feeding, or pregnancy planning person
4.Those who are scheduled to undergo surgery / hospitalization, etc. for two months before and after the examination period (November 2017 to February 2018)
5.Persons who are judged unsuitable for participating in this trial by the principal investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Segawa |
Organization
SAPPORO HOLDINGS Ltd.
Division name
Frontier Laboratory for Value Creation
Zip code
Address
10 Okatohme, Yaizu city, Shizuoka, 425-0013 JAPAN
TEL
054-629-7982
Syuuichi.segawa@sapporoholdings.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Segawa |
Organization
SAPPORO HOLDINGS Ltd.
Division name
Frontier Laboratory for Value Creation
Zip code
Address
10 Okatohme, Yaizu city, Shizuoka, 425-0013 JAPAN
TEL
054-629-7982
Homepage URL
Syuuichi.segawa@sapporoholdings.co.jp
Sponsor or person
Institute
SAPPORO HOLDINGS Ltd.
Frontier Laboratory for Value Creation
Institute
Department
Personal name
Funding Source
Organization
SAPPORO HOLDINGS 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
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
| 2019 | Year | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | 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 | 12 | Month | 28 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034967
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
