UMIN-CTR Clinical Trial

Basic information
Public title	A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Acronym	A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Scientific Title	A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Scientific Title:Acronym	A Study to Evaluate the Safety of Long Term Consumption of Food Containing Plant Extract.
Region	Japan

Condition
Condition	Healthy Adult (including borderline diabetes)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of long term consumption of food containing plant extract for 12 weeks in healthy adults.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Inquiry, physical examination, medical examination by hematology,blood biochemistry, urinalysis.
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	Test food containing plant extract, 12 weeks 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) 20<=Age=<64 of healty men and women (2) Subjects who are judged as normoglycemic or borderline diabetes by the investigator (3) Subjects who can make self-judgments and voluntarily give written informed consents
Key exclusion criteria	(1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases (2) Subjects with a disorder in heart and lung function (3) Subjects with abnormal parameters in liver or kidney function (4) Subjects who had a gastrointestinal surgery (5) Subjects with a disease currently under treatment (6) Subjects with drug or food allergies (7) Subjects with anemic (8) Subjects who play high intensity sports or are on a diet (9) Subjects who are taking supplemental foods, quasi drugs or drug products (including OTC or prescribed medication) containing ingredient of test food (10) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol at one day prior to the test day and the day of the test (11) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period (12) Subjects who is participating in other studies or planning to participate during the study period (13) Subjects who are deemed unsuitable 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	tterashima@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	tterashima@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	2017 Year 02 Month 26 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 02 Month 17 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 28 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 02 Month 24 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=R000030145