UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA on postprandial hyperglycemia : randomized, placebo-controlled, double blind cross-over trial
Title of the study (Brief title)	A study for evaluating the effect of suppressing of blood glucose level after meals of the intake of food containing HYA
Region	Japan

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

Objectives
Narrative objectives1	To investigate the dose-finding of effect of food containing HYA on postprandial hyperglycemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve of plasma glucose levels
Key secondary outcomes	Postprandial blood glucose, maximum plasma glucose levels, postprandial insulin levels

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of food without HYA (single ingestion) - washout period - food containing HYA (single ingestion)
Interventions/Control_2	Intake of food containing HYA (single ingestion) - washout period - food without HYA (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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and females from 20 to 69 years of age 2) postprandial blood glucose levels are ranged from 140 mg/dL to 199 mg/dL
Key exclusion criteria	1) Subjects who routinely use health food containing large amount of unsaturated fatty acids or health food for diet 2) Subjects routinely taking medicine or health food which may influence glucose metabolism 3) Subjects who have body mass index (BMI) less than 18.5 kg/square meter or more than 30.0 kg/square meter 4) Subjects who have fasting blood glucose more than 126 mg/dL on preliminary examination 5) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) 6) Subjects having possibilities for emerging allergy related to the current study 7) Subjects who are under medication or having a history of serious diseases for which medication was required 8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination 9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 12) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	Yasunori Yonejima
Organization	NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Division name	Research and Development Division
Address	35-3, Minamibiraki., Kamiueno-cho, Muko-shi Kyoto
TEL	075-921-5344
Email	y.yonejima@nitto-ph.com

Public contact
Name of contact person	Shinsuke Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	NITTO PHARMACEUTICAL INDUSTRIES 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 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 13 Day
Anticipated trial start date	2017 Year 08 Month 03 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 08 Month 03 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032626