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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031397
Receipt No. R000035845
Scientific Title The effect of mastication on feeding center: relationship between changes in glycometabolism and hormone dynamics and central nervous system
Date of disclosure of the study information 2018/02/20
Last modified on 2019/02/21

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Basic information
Public title The effect of mastication on feeding center: relationship between changes in glycometabolism and hormone dynamics and central nervous system
Acronym The effect of mastication on appetite
Scientific Title The effect of mastication on feeding center: relationship between changes in glycometabolism and hormone dynamics and central nervous system
Scientific Title:Acronym The effect of mastication on appetite
Region
Japan

Condition
Condition Obesity population
Classification by specialty
Medicine in general Endocrinology and Metabolism Dental medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether mastication affect glycometabolism, hormone dynamics, or brain activation pattern
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in cerebral blood flow dynamics after administration of glucose solution are compared and examined with or without chewing.
All subjects conduct experiments on different days under chewing conditions or control conditions (without chewing).
Brain function measurement is performed by functional MRI imaging.
Key secondary outcomes Regarding blood tests, subjects took a total of 7 blood draws before gum chewing (5 minutes before glucose administration in control experiments) and immediately after glucose administration (0), 10, 20, 30, 40 and 50 minutes . At that time, the concentrations of glucose, insulin, leptin, ghrelin, PYY (peptide YY), GLP-1 (glucagon-like peptide 1), GIP (glucose-dependent secretion stimulating polypeptide), CCK (cholecystokinin) are measured.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The tasteless and odorless gum was chewed for 5 minutes, and the cerebral blood flow dynamics and hemodynamics after chewing are compared and examined.
During gum chewing, glucose 75 g solution is orally administered 300 ml.
Interventions/Control_2 In the control condition, cerebral blood flow dynamics and hemodynamics after resting without chewing are compared and examined.
In the resting state, glucose 75 g dissolved solution is orally administered at 300 ml.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants are recruited from the students of Tokyo medical and dental university.
Key exclusion criteria They fulfilled following exclusion criteria: (i) history of metabolic, neurological, or psychiatric diseases or any eating disorders, (ii) use of any medication, (iii) current or recent efforts to lose weight, (iv) pregnant, (v) BMI > 25 kg/m2.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Moriyama
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan
Division name Maxillofacial Orthognathics, Division of Maxillofacial and Neck Reconstruction
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
TEL 03-5803-5532
Email k-moriyama.mort@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun J Miyamoto
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Maxillofacial Orthognathics, Division of Maxillofacial and Neck Reconstruction
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, TOKYO , 113-8549, JAPAN
TEL 03-5803-5569
Homepage URL
Email mjmort@tmd.ac.jp

Sponsor
Institute Maxillofacial Orthognathics, Division of Maxillofacial and Neck Reconstruction, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan
Institute
Department

Funding Source
Organization JSPS Grant-in-Aid for Young Scientists (A) Grant Number 26713055.
Organization
Division
Category of Funding Organization Japanese Governmental office
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 02 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 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 02 Month 20 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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