UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036918 |
|---|---|
| Receipt number | R000042070 |
| Scientific Title | Masticatory behavior and its influence on anthropometric and metabolic indices: analysis of 3-day self recorded video-based dietary assessment in free-living adults |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/06/01 04:39:14 |
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Basic information
Public title
Masticatory behavior and its influence on anthropometric and metabolic indices: analysis of 3-day self recorded video-based dietary assessment in free-living adults
Acronym
Masticatory behavior and its influence on anthropometric and metabolic indices: analysis of 3-day self recorded video-based dietary assessment in free-living adults
Scientific Title
Masticatory behavior and its influence on anthropometric and metabolic indices: analysis of 3-day self recorded video-based dietary assessment in free-living adults
Scientific Title:Acronym
Masticatory behavior and its influence on anthropometric and metabolic indices: analysis of 3-day self recorded video-based dietary assessment in free-living adults
Region
| Asia(except Japan) |
Condition
Condition
Mastication
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between masticatory behavior and anthropometric indices of obesity
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of masticatory behavior modification on metabolic parameters, energy intake and appetite score in obese adults
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Chewing count per bite
2. Chewing rate
3. Bite rate
4. Meal duration
Key secondary outcomes
1. Total energy and macronutrients intake
2. Chewing 50% times more than pre-intervention on metabolic parameters which include postprandial plasma glucose, total plasma [cholesterol], plasma [triglyceride] and plasma [uric acid]
3. Chewing 50% times more than pre-intervention on hunger, satiety, appetite via visual analogue scale (VAS) questionnaire
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Chewing 50% more than pre-intervention chewing count
Interventions/Control_2
Pre-intervention chewing count
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Non-smoker
2. Not underweight
3. Not pregnant
4. No eating or digestive disorders
5. having complete set of natural healthy teeth
Key exclusion criteria
1. Restricted function of the mouth, face, or jaws
2. Bruxism
3. Receiver of any investigational research agents within the previous 3 months
4. >3 kg weight fluctuation within the previous 5 months
5. Diagnosed diabetes
6. Facial hair preventing observation of jaw movement
7. Currently following a calorie restricted diet
Target sample size
49
Research contact person
Name of lead principal investigator
| 1st name | Adam |
| Middle name | |
| Last name | Linoby |
Organization
Universiti Teknologi MARA
Division name
Faculty of Sports Science and Recreation
Zip code
70300
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremba n, Negeri Sembilan, Malaysia
TEL
+60133632005
linoby@uitm.edu.my
Public contact
Name of contact person
| 1st name | Adam |
| Middle name | |
| Last name | Linoby |
Organization
Universiti Teknologi MARA
Division name
Faculty of Sports Science and Recreation
Zip code
70300
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremba n, Negeri
TEL
+60133632005
Homepage URL
linoby@uitm.edu.my
Sponsor or person
Institute
Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department
Personal name
Funding Source
Organization
Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Address
UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3
Tel
+606-6342409
shari0971@uitm.edu.my
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
| 2019 | Year | 06 | Month | 01 | 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
52
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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | 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 | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042070
