UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the test food containing plant extract on postprandial blood glucose
Acronym	Effect of the test food containing plant extract on postprandial blood glucose
Scientific Title	Effect of the test food containing plant extract on postprandial blood glucose
Scientific Title:Acronym	Effect of the test food containing plant extract on postprandial blood glucose
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the test food on postprandial blood glucose
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AUC of blood glucose levels
Key secondary outcomes	Postprandial blood glucose levels at 30, 60, 90 and 120 minutes after meal, AUC of blood insulin levels, Postprandial blood insulin levels at 30, 60, 90 and 120 minutes after meal

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single intake of the placebo food -> Washout period -> Single intake of the test food 2 -> Washout period -> Single intake of the test food 1
Interventions/Control_2	Single intake of the test food 1 -> Washout period -> Single intake of the placebo food -> Washout period -> Single intake of the test food 2
Interventions/Control_3	Single intake of the test food 2 -> Washout period -> Single intake of the test food 1 -> Washout period -> Single intake of the placebo food
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)Males and females aged 20 to 64 years 2)Healthy subjects whose screening test results are not greatly out of nomal range 3)Subjects whose fasting blood glucose levels are less than 126 mg/dL, postprandial blood glucose levels are 140 mg/dL or more at 30 or 60 minutes after meal and 199 mg/dL or less at 120 minutes after meal 4)Subjects who agree to participate and can write signature and date in the written informed consent
Key exclusion criteria	1)Subjects who have a history of serious disease or digestive surgery (except for appendectomy) 2)Subjects who are considered as diabetes or have a history of that 3)Subjects who have serious complications or chronic disease 4)Subjects who habitually take medicine or supplements which may affect blood glucose level 5)Subjects who have allergy to the test food or rice 6)Subjects who are pregnant, lactating, or planning to get pregnant 7)Heavy drinker (more than 60g of alcohol per day) or heavy smoker (more than 20 cigarettes per day) 8)Subjects who are planning to participate in other clinical study during the study period 9)Subjects who have restrictions on the test food or meal for religious or other reasons 10)Subjects who are considered as an inappropriate candidate for other reasons by the doctor in charge
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Ishikawa
Organization	Medical Corporation Shoureikan Sapporo Yushokan Hospital
Division name	Internal Medicine
Zip code	002-8042
Address	2-8-25, 2-jo, Higashibarato, Kita-ku, Sapporo, Hokkaido
TEL	011-772-9211
Email	Ishikawa_seiryo@yahoo.co.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Takehara
Organization	Clinical Support Corporation Co., Ltd
Division name	PI-Food Service Division
Zip code	060-0061
Address	8-4-1, Minami 1-jo, Chuo-ku, Sapporo, Hokkaido
TEL	011-223-3130
Homepage URL
Email	takehara@csc-smo.co.jp

Sponsor
Institute	Medical Corporation Shoureikan Sapporo Yushokan Hospital
Institute
Department

Funding Source
Organization	KOBAYASHI Pharmaceutical 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 Medical Corporation Hokubukai Utsukushigaoka Hospital
Address	61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel	011-82-0111
Email	matsuda@ughp-cpc.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 10 Month 09 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	2020 Year 09 Month 03 Day
Date of IRB	2020 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2020 Year 11 Month 30 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 10 Month 08 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047887