UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048863 |
|---|---|
| Receipt number | R000055682 |
| Scientific Title | Mastication by gum chewing influences Glucagon-like Peptide 1 (GLP-1) secretion after a meal test in healthy adult women |
| Date of disclosure of the study information | 2022/09/06 |
| Last modified on | 2022/09/06 15:12:58 |
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Basic information
Public title
Mastication by gum chewing influences Glucagon-like Peptide 1 (GLP-1) secretion after a meal test in healthy adult women
Acronym
Mastication by gum chewing influences Glucagon-like Peptide 1 (GLP-1) secretion after a meal test in healthy adult women
Scientific Title
Mastication by gum chewing influences Glucagon-like Peptide 1 (GLP-1) secretion after a meal test in healthy adult women
Scientific Title:Acronym
Mastication by gum chewing influences Glucagon-like Peptide 1 (GLP-1) secretion after a meal test in healthy adult women
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mastication has, in recent years, been observed to improve postprandial glucose metabolism. However, the effects of mastication remain unclear due to methodological differences among studies. Herein, we verified mastication effects on glucose metabolism by examining different chewing durations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma glucose (PG), hemoglobin A1c (HbA1c), serum insulin and GLP-1
Key secondary outcomes
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
| Behavior,custom |
Interventions/Control_1
Gum chewing for 15
Interventions/Control_2
Gum chewing for 30
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Twenty-four females volunteered to participate in this study at Wayo Women's University in Ichikawa
Key exclusion criteria
Uncomfortable with blood sampling,Poor physical condition (due to autonomic reflexes) during blood sampling,Unable to tolerate needle pain of blood sampling,Consumed another food during trial period
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kurioka |
Organization
Wayo Women's University
Division name
Faculty of Human Ecology
Zip code
272-8533
Address
2-3-1,Konodai,Ichikawa City,Chiba Pref,Japan
TEL
047-371-1632
y-kurioka@wayo.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kurioka |
Organization
Wayo Women's University
Division name
Faculty of Human Ecology
Zip code
272-8533
Address
2-3-1,Konodai,Ichikawa City,Chiba Pref,Japan
TEL
047-371-1632
Homepage URL
y-kurioka@wayo.ac.jp
Sponsor or person
Institute
Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
Yazuya Institute of Food and Health
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wayo Women's University
Address
2-3-1,Konodai,Ichikawa City,Chiba Pref,Japan
Tel
047-371-1632
y-kurioka@wayo.ac.jp
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
和洋女子大学（Wayo Women's University）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055682
