UMIN-CTR Clinical Trial

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
Email	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/
Email	kmatsuo@fujita-hu.ac.jp

Sponsor
Institute	Dentistry and oral-maxillo surgery, school of medicine, Fujita Health University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034354