UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial
Title of the study (Brief title)	Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial (GUM-CHEWING SIGHT study)
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the effect of gum chewing before meal on insulin, glucagon, and gastrointestinal hormones (ghrelin and GLP-1). <the hypothesis of this study> The gum chewing before meal suppresses the postprandial plasma glucose increase or decreases the postprandial plasma glucose, promotes gastrointestinal hormone secretion, decreases glucagon secretion, and induces plasma glucose-responsive insulin secretion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences of changes in plasma glucose, insulin, glucagon, and gastrointestinal hormones (ghrelin and GLP-1) from before meal to after meal.
Key secondary outcomes	Differences of changes in subjective evaluation scores in study subjects' hunger, fullness, desire to eat, and preoccupation measured by visual analog scale with food from before meal to after meal.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Study subjects will perform different meal load tests over 3 days. Each meal load test will be conducted with at least 1 week interval. <No gum before meal> Study subjects take test meal 1 in test meal load. Study subjects engulf each 1/12 of the test meal 1 after chewing it 30 times. Study subjects continue the above 12 times to complete the test meal 1. * Test meal 1 is "Sato-No-Gohan" (polished rice, 200 g), including energy 294 kcal, protein 4.2 g, lipid 0 g, carbohydrate 67.8 g, and sodium 0 mg (manufactured by Sato Foods Co., Ltd.) <Gum-chewing before meal> Study subjects take test meal 1 after chewing test meal 2 in test meal load. Study subjects chew test meal 2 15 min at a speed of 80 times/min. Study subjects eat the test meal 1 as a same method with the no-gum group after the test meal 2 chewing. * test meal 2 edible tasteless gum (1 g): tasteless, non-calorie gum, (manufactured by LOTTE Co., Ltd.) Group A day 1: Gum-chewing before meal day 2: No gum before meal day 3: Gum-chewing before meal
Interventions/Control_2	Group B day 1: No gum before meal day 2: Gum-chewing before meal day 3: No gum before meal
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male
Key inclusion criteria	Subjects who meet all of the following criteria are included in this study. 1. healthy volunteers without glucose metabolism disorder 2. subjects with normal dental occlusion without any structural or functional disorder in stomatognathic system 3. subjects who does not receive any pharmacological treatments 4. males who are aged of 30 years or older and younger than 50 years when giving their consent 5. subjects who provide written consent form to participate in this study after full explanation of the study
Key exclusion criteria	Subjects who fall into any of the following criteria are excluded from participating in the study. 1. subjects with dementia or psychiatric disorder, or those who need legal representatives for providing their consent 2. subjects with alcoholics 3. subjects with hearing disorder 4. subjects with other conditions that the investigator/researcher thinks inappropriate for the study
Target sample size	16

Research contact person
Name of lead principal investigator	Masahiro Fukuda
Organization	Fukuda Clinic
Division name	Internal Medicine, Ambulatory Diabetes Care
Address	Shin-Osaka brick building 2F, 1-6-1, Miyahara, Yodogawa, Osaka, Osaka
TEL	06-6398-0203
Email	fukudaclinic@drmog.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Osaka Association of General Physician
Institute
Department

Funding Source
Organization	LOTTE 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	2018 Year 09 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 09 Day
Anticipated trial start date	2018 Year 09 Month 19 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	2018 Year 09 Month 18 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038975