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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034185
Receipt No. R000038975
Scientific Title Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial
Date of disclosure of the study information 2018/09/18
Last modified on 2019/03/04

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Basic information
Public title Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial
Acronym Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial (GUM-CHEWING SIGHT study)
Scientific Title Effect of GUM-CHEWING before meal on postprandial plasma glucose, Secretion of Insulin, Glucagon and gastrointestinal Hormones, healthy volunteer Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiro Fukuda
Organization Fukuda Clinic
Division name Internal Medicine, Ambulatory Diabetes Care
Zip code
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
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 08 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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