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, Physical measurement, Physical examination, Blood test (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	Food 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose BMI are under 30. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease). (2) Subjects with abnormal parameters in liver and/or kidney function. (3) Subjects who had a gastrointestinal surgery. (4) Subjects with a disease currently under treatment. (5) Subjects with drug or food allergies. (6) Subjects with anemic. (7) Subjects who play high intensity sports and/or are on a diet. (8) Subjects with irregular life patterns. (9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods. (10) Subjects who are under treatment with medications (including OTC and/or prescribed medications). (11) Subjects who drink excessive alcohol. (12) Subjects who can't stop drinking from one day before each measurement. (13) Subjects who are pregnant, planning to become pregnant or lactating during the current study period. (14) Subjects who are participating in other studies or planning to participate at the start of the current study. (15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	530-0044
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	mterashima@miula.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Zip code	530-0044
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Oneness support Co., Ltd.
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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	mterashima@miula.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	2021 Year 05 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	2021 Year 04 Month 15 Day
Date of IRB	2021 Year 04 Month 22 Day
Anticipated trial start date	2021 Year 05 Month 13 Day
Last follow-up date	2021 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 07 Day
Last modified on	2021 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050393