UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034185
Receipt number 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 18:16:52

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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 or person

Institute

Osaka Association of General Physician

Institute

Department

Personal name



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

Value
https://center6.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