UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030090 |
|---|---|
| Receipt number | R000034354 |
| Scientific Title | The effects of eating of masticatory functional food and exercise therapy on general and oral functions: Cluster randomized control study |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/04/13 16:07:49 |
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Basic information
Public title
The effects of eating of masticatory functional food and exercise therapy on general and oral functions: Cluster randomized control study
Acronym
The effects of eating of masticatory functional food and exercise on general and oral functions
Scientific Title
The effects of eating of masticatory functional food and exercise therapy on general and oral functions: Cluster randomized control study
Scientific Title:Acronym
The effects of eating of masticatory functional food and exercise on general and oral functions
Region
| Japan |
Condition
Condition
n/a
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of eating of masticatory functional food, the instruction of nutrition and oral health, and exercise therapy on general and oral functions by a randomized control study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The change rate of general muscle mass, muscle strength and motor function after 12 weeks intervention
Key secondary outcomes
The change rate of oral functions after 12 weeks intervention
The change rate of QOL and appetite after 12 weeks intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Providing masticatory functional bento twice a week to participants with
Interventions/Control_2
Providing bento twice a week and 12 weeks
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. given fully informed consent
2. individuals who eat the provided bento for 12 weeks.
Key exclusion criteria
1. individuals who have allergy for foods
2. severe renal failure
3. severe impairment of masticatory and swallowing functions
4. individuals whom the investigators judge improper
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsuo |
Organization
Fujita Health University
Division name
dentistry and oral-maxillo surgery, school of medicine
Zip code
4701192
Address
1-98 dengakugakubo, kutsukake, toyoake, aichi
TEL
0562-93-9098
kmatsuo@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsuo |
Organization
Fujita Health University
Division name
dentistry and oral-maxillo surgery, school of medicine
Zip code
4701192
Address
1-98 dengakugakubo, kutsukake, toyoake, aichi
TEL
0562-93-9098
Homepage URL
http://dentistryfujita-hu.jp/
kmatsuo@fujita-hu.ac.jp
Sponsor or person
Institute
Dentistry and oral-maxillo surgery, school of medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Food care
Matsumoto Dental University
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo Kutsukake, Toyoake
Tel
0562-93-2000
kmatsuo@fujita-hu.ac.jp
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 | 01 | Day |
Related information
URL releasing protocol
https://www.goindependent.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.goindependent.jp/
Number of participants that the trial has enrolled
86
Results
Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group. Physical properties and activities, including body fat percentage and results of the timed up and go test, decreased more significantly in the intervention group than in controls (p<0.05).
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mean age 75.6 years old
men:women　6:80
Participant flow
A total of 113 older adults were recruited for this study and allocated into the intervention or control groups randomly according to community group (Figure 3). Five subjects in the control group and 12 in the intervention group withdrew from the study due to lack of interest or hospitalization. Ultimately, each 43 subjects in the control and intervention groups completed the final physical and oral assessments.
Adverse events
none
Outcome measures
5 Oral function
6 physical properties and activities
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034354
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