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
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
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
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
