UMIN-CTR Clinical Trial

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
Email	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
Email	y-kurioka@wayo.ac.jp

Sponsor
Institute	Wayo Women's University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055682