UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1 -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym	A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
Scientific Title	A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1 -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
Region	Japan

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

Objectives
Narrative objectives1	To comfirm the effect of food containing plant extract on Postprandial GLP-1
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	GLP-1
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Interventions/Control_2	Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single ingestion.
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. (2)Subjects who do not habitually consume a large amounts of alcohol. (3)Subjects who are judged not suffering from a disease by the investigator. (4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1)Subjects who have a chronic disease and regularly use medications. (2)Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods. (3) Subjects who can't stop drinking from 2 days before each measurement. (4)Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods. (5) Subjects who contract or are under treatment for diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). (6)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (7)Subjects who are judged unsuitable for the current study by the screening tests. (8)Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling. (9) Subjects who have had diarrhea within the last one week prior to the screening tests. (10)Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study. (11)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (12) Subjects who are shiftworker and/or midnight-shift worker. (13) 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. (14) Subjects who are planning to become pregnant after informed consent, pregnant or lactating. (15) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name Tokushima
Organization	Maebashi North Hospital
Division name	Director
Zip code	371-0054
Address	692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL	027-235-3333
Email	sagawa@mc-connect.co.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	5-656-17 Joto-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	2020 Year 07 Month 08 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046828
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49020/321
Number of participants that the trial has enrolled	12
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2021 Year 10 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 20 to 64 years old.
Participant flow	Enrolled(n=12) Completed(n=11) Analysed(n=7)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	GLP-1
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 06 Month 24 Day
Date of IRB	2020 Year 07 Month 02 Day
Anticipated trial start date	2020 Year 07 Month 09 Day
Last follow-up date	2020 Year 08 Month 15 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 07 Month 06 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046828