UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024115 |
|---|---|
| Receipt number | R000027761 |
| Scientific Title | The effect of mastication on feeding center: the analysis from the cognitive aspect using visual stimuli. |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2024/03/13 12:15:11 |
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Basic information
Public title
The effect of mastication on feeding center: the analysis from the cognitive aspect using visual stimuli.
Acronym
The effect of mastication on appetite
Scientific Title
The effect of mastication on feeding center: the analysis from the cognitive aspect using visual stimuli.
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 investigates whether mastication reduces attentional bias to food and the subjective appetite.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Experiment 1: Assessments of hunger scales (hunger, fullness, preoccupation with food, desire to eat) with VAS (visual analogue scales), Reaction Time (RT) bias scores (calculated by subtracting the mean RTs to food images from the mean RTs to nonfood images) 1) before and after chewing gum and 2) before and after eating food.
Experiment 2: Assessments of hunger scales (same as Experiment 1) with VAS, RT bias scores (same as Experiment 1), duration bias scores and direction bias scores to food with eye-tracking (ET) 1) before and after chewing gum and 2) before and after eating food.
Key secondary outcomes
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
In Experiment 1, a VPT and subjective ratings of appetite, using visual analogue scales (VAS), were conducted. In Experiment 2, a VPT with ET and VAS ratings were conducted. Participants for both experiments attended on two separate days: one day a chewing gum session. VPT or VPT with ET were each performed twice: once before and once after chewing gum. Subjective appetite was rated four times in each session using VAS: T1, before the first VPT or VPT with ET; T2, before chewing gum; T3, after chewing gum; and T4, after the second VPT or VPT with ET.
Interventions/Control_2
In Experiment 1, a VPT and subjective ratings of appetite, using VAS, were conducted. In Experiment 2, a VPT with ET and VAS ratings were conducted. Participants for both experiments attended on two separate days: the other a food eating session to create the condition of satiety as control session. VPT or VPT with ET were each performed twice: once before and once after consuming standardized food. Subjective appetite was rated four times in each session using VAS: T1, before the first VPT or VPT with ET; T2, before consuming food; T3, after consuming food; and T4, after the second VPT or VPT with ET.
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 were 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
東京医科歯科大学歯学部附属病院（東京）
Tokyo Medical and Dental University, Faculty of Dentistry, Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | 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=R000027761
