UMIN-CTR Clinical Trial

Basic information
Public title	The effect of mastication on postprandial glucose metabolism
Acronym	The effect of mastication on postprandial glucose metabolism
Scientific Title	The effect of mastication on postprandial glucose metabolism
Scientific Title:Acronym	The effect of mastication on postprandial glucose metabolism
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to clarify the effect of physiological mastication (chewing) on postprandial glucose metabolism and gastric excretion.
Basic objectives2	Others
Basic objectives -Others	A participant will conduct 2 trials, mealtests with and without mastication. In the mealtest without mastication, participant will take a grinded testmeal, which has same nutrient composition as the trial with mastication, dissolved in water. The effect of mastication itself on postprandial glucose metabolism and gastric excretion independent of nutrient composition of the testmeal.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	plasma glucose levels (baseline, 15, 30, 45, 60, 90, and 120 min after taking a testmeal)
Key secondary outcomes	serum insulin and acetoaminophen levels, plasma GLP-1 level, postprandial energy expenditure

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	a bout of mealtest with mastication
Interventions/Control_2	a bout of mealtest without mastication
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults with no present illness
Key exclusion criteria	a person taking oral hypoglycemic agents or insulin injection/a person with peptic ulcer/a person suffering from or has a history of aspirin-indiced asthma/oral diseases (doesnot matter whether having any prosthetic appliances or not)
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hisayo Middle name Last name Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Zip code	558-8585
Address	3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL	06-6605-2947
Email	yokoyama@sports.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Hisayo Middle name Last name Yokoyama
Organization	Osaka City University Graduate School of Medicine
Division name	Environmental Physiology for Exercise
Zip code	558-8585
Address	3-3-138, Sugimoto, Sumiyoshi-ku, Osaka City
TEL	06-6605-2947
Homepage URL
Email	yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
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	Osaka City University 0Certified Review Board for Medical Research
Address	1-2-7-601, Asahi-Machi, Abeno-ku, Osaka City
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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	大阪市立大学環境生理実験室

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 25 Day

Related information
URL releasing protocol	none (paper only)
Publication of results	Published

Result
URL related to results and publications	none (paper only)
Number of participants that the trial has enrolled	8
Results	Eight healthy young individuals participated in the experiments for a two-meal test, in a crossover design. The postprandial blood glucose and insulin levels in the Chewing trial peaked significantly earlier than those in the Non-Chewing trial. The AUC of acetaminophen level in the Chewing trial was significantly greater than the Non-chewing trial The DIT was similar in the two trials.
Results date posted	2021 Year 06 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	healthy young adults
Participant flow	participated in the experiments for a two-meal test by invitation, in a crossover design
Adverse events	none
Outcome measures	gastric excretion postprandial blood glucose, insulin diet-induced thermogenesis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 25 Day
Date of IRB	2019 Year 04 Month 25 Day
Anticipated trial start date	2019 Year 07 Month 22 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042344