UMIN-CTR Clinical Trial

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
Email	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
Email	uetake@cx-wellness.com

Sponsor
Institute	Sasaki Medical Hospital,Kazumotokai MedicalCorporation.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045381