UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of chewing or dietary fiber intake on blood glucose
Title of the study (Brief title)	Chewing, dietary fiber and blood glucose
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether favorable effect of postprandial hyperglycemia is chewing or dietary fiber.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose of 30min, 60min and 120min and AUC of blood glucose
Key secondary outcomes	Insulin, GLP-1 and Serum lipids

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Chewing gum before a meal protocol is performed and then eating cabbage before a meal is performed after one week wash out period.
Interventions/Control_2	Eating cabbage before a meal is performed and then chewing gum before a meal is performed after one week wash out period.
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	Outpatient in clinic at Kyoto Prefectural University of Medicine 1.No medication. 2.HbA1c is less than 7%.
Key exclusion criteria	The patient who judged that the chief physician was unsuitable for examination participation in planning. The patient who expressed non-consent of the participation.
Target sample size	10

Research contact person
Name of lead principal investigator	Michiaki Fukui
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	0752515505
Email	sayarinapm@hotmail.com

Public contact
Name of contact person	Yoshitaka Hashimoto
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name	Department of Endocrinology and Metabolism
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	0752515505
Homepage URL
Email	y-hashi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Department of Endocrinology and Metabolism
Organization
Division
Category of Funding Organization	Self funding
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	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 11 Month 26 Day
Last modified on	2017 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023028