UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039789 |
|---|---|
| Receipt number | R000045381 |
| Scientific Title | Safety evaluation of excessive intake of polyphenol. |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/03/12 17:04:31 |
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Basic information
Public title
Safety evaluation of excessive intake of polyphenol.
Acronym
Safety evaluation of polyphenol.
Scientific Title
Safety evaluation of excessive intake of polyphenol.
Scientific Title:Acronym
Safety evaluation of polyphenol.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of polyphenol.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) The incidence of side effects and/or adverse events.
(2) The results of clinical examination.
Key secondary outcomes
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 polyphenol for 4 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between the ages of 20 and under 75 who wish to voluntarily participate in clinical trials and obtain written consent.
(2) Healthy subjects who have not taken any treatment or medication for the disease.
(3) Subjects who can maintain their daily habits during the test period.
Key exclusion criteria
(1) Subjects with serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness.
(2)Subjects with a history of serious illness. (diabetes, heart disease, liver disease, kidney disease, cancer, etc.)
(3)Subjects who have large changes in diet and exercise and cannot maintain their daily lifestyle.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Sasaki |
Organization
Sasaki Medical Hospital,Kazumotokai MedicalCorporation
Division name
Director
Zip code
359-1144
Address
1-7-25 Nishitokorozawa, Tokorozawa-shi, Saitama-ken 359-1144 Japan
TEL
0429-23-7751
soumuka@sasaki-memorial.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
CEO
Zip code
103-0023
Address
516 Nihonbashinagatani Bldg.,3-1-6,Nihonbashihoncho, Chuo-ku, Tokyo,Japan.
TEL
03-6225-5601
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Sasaki Medical Hospital,Kazumotokai MedicalCorporation.
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
Ueno asagao clinic
Address
2-7-5, Higashiueno, Taito Ku, Tokyo To, 110-0015, Japan
Tel
03-6240-1162
info@ueno-asagao.clinic
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
| 2020 | Year | 03 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045381
