UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of food containing dietary fiber on inhibitory effect of postprandial blood glucose level - placebo-control, open labeled, crossover trial
Title of the study (Brief title)	Exploratory study of food containing dietary fiber on inhibitory effect of postprandial blood glucose level
Region	Japan

Condition
Condition	Borderline of hyperglycemia
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore inhibitory effect of food containing dietary fiber on postprandial blood glucose level
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve (AUC) of postprandial blood glucose level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Subjects will take the food containing dietary fiber once on the test day. After more than 5 days of washout period, subjects will take the food not containing dietary fiber once on the test day.
Interventions/Control_2	Subjects will take the food not containing dietary fiber once on the test day. After more than 5 days of washout period, subjects will take the food containing dietary fiber once on the test day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 20 years of age or older. 2) 110 mg/dL <= FPS <= 125 mg/dL. 3) Understanding the study and submitting the written informed consent before the study.
Key exclusion criteria	1) With diabetes mellitus or glucose metabolism disorder. 2) Females in pregnancy, lactation and scheduled pregnancy period. 3) With heart disorder liver disorder, and kidney disorder 4) With previous or present cardiac disorder. 5) With allergy to drugs or foods. 6) Use of product affecting the data of this study, such as medicine, food for specified health use, food with function claims, supplement, diet food. 7) Investigator's judgment for other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	Junichi Nakamura
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	2-3-3 Daiba, Minato-ku, Tokyo 135-8631 Japan
TEL	03-5579-1277
Email	Junichi_Nakamura@suntory.co.jp

Public contact
Name of contact person	Akifumi Maeda
Organization	Suntory Business Expert Limited
Division name	HE Center
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0719
Homepage URL
Email	Akifumi_Maeda@suntory.co.jp

Sponsor
Institute	Suntory Business Expert Limited
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Suntory Beverage & Food Limited
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	2015 Year 09 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 17 Day
Anticipated trial start date	2015 Year 09 Month 27 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	2015 Year 09 Month 18 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022045