UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036918
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email linoby@uitm.edu.my

Sponsor
Institute Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.