UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031397 |
|---|---|
| Receipt number | 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 | 2024/03/13 12:15:37 |
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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
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
mjmort@tmd.ac.jp
Sponsor or person
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
Personal name
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
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
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035845
