UMIN-CTR Clinical Trial

Basic information
Public title	A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract -Open Study-
Acronym	A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
Scientific Title	A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract -Open Study-
Scientific Title:Acronym	A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Plant Extract
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive consumption of food containing plant extract
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Doctor's questions, Vital signs, Hematological test, Blood biochemical test, Urinalysis, Adverse event
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	Foods containing plant extract, 4 weeks excessive consumption
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged 20 to 64 years-old whose BMI are under 30. (2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who are under treatment with medications. (2) Subjects who contract or are undertreatment for serious diseases (e.g., kidney disease, liver disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disease). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods. (4) Subjects who can't stop drinking from 2 days before each measurement. (5) Subjects who have declared allergic reaction to ingredients of test foods. (6) Subjects who have donated over 400mL of blood and/or bood components within the last three months prior to study initiation. (7) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating. (8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (9) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study. (10) Subjects who are judged as unsuitable for the current study by the investigator or subinvestigators for other reasons.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., 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	Ethical Committee of Kobuna Orthopedics Clinic
Address	311-2 Gokan-machi, Maebashi-shi, Gumma
Tel	027-212-5608
Email	sagawa@mc-connect.co.jp

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	2018 Year 10 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	Completed
Date of protocol fixation	2018 Year 10 Month 04 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 10 Month 13 Day
Last follow-up date	2018 Year 12 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 12 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039290