UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Title of the study (Brief title)	A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the test products on postprandial hyperglycemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incremental area under the curve of plasma glucose
Key secondary outcomes	Peak in plasma glucose concentration, fasting plasma glucose , plasma glucose at 15, 30, 45, 60, 90, and 120 min.

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	Intake of the standard products,Intake of the test products
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	50 years-old >=
Gender	Male
Key inclusion criteria	(1)Males from 20 to 50 years of age. (2)Subjects who have a difference of incremental area under the curve of plasma glucose levels between preliminary examination 1 and preliminary examination 2 within 25 percent.
Key exclusion criteria	(1)Subjects routinely taking medicine or health food which may influence glucose metabolism. (2)Subjects who have abnormal glucose tolerance within the one month prior on preliminary examination. (3)Subjects who have body mass index (BMI) less than 18.5 kg per square meter or more than 25.0 kg per square meter. (4)Subjects who have abnormal glucose tolerance on preliminary examination (5)Subjects who work at night or have irregular life more than one time in the study. (6)Subjects who are planning to go overseas. (7)Subjects with allergies to the test food in the study. (8)Subjects who drink alcohol a lot. (9)Subjects who smoke a lot. (10)Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease, digestive system disease. (11)Subjects who have a disease under medication or having a history of study such as obesity, dyslipidemia, hypertension or who has a serious disease. (12)Subject who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements. (13)Subjects who have participated in other clinical study within the last one month or have planned to participate other clinical studies. (14)Subjects who are judged as unsuitable for the study from questionnaire. (15)Subjects who are judged as ineligible by clinical investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	Shigeki Satomi
Organization	House Foods Co., Ltd
Division name	Research & Development institute
Address	1-4, Takanodai, Yotsukaido, Chiba
TEL	043-237-5211
Email	s-satomi@housefoods.co.jp

Public contact
Name of contact person	Noriko Watanabe
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	n.watanabe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	House Foods Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 03 Day
Last modified on	2017 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029884