UMIN-CTR Clinical Trial

Basic information
Public title	Research on prevention of low nutritional state for elderly person using chewing-gum
Acronym	Research on prevention of low nutritional state for elderly person using chewing-gum
Scientific Title	Research on prevention of low nutritional state for elderly person using chewing-gum
Scientific Title:Acronym	Research on prevention of low nutritional state for elderly person using chewing-gum
Region	Japan

Condition
Condition	oral hypofunction
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Objective of this research is the improvement of oral function of elderly person using chewing-gum to prevent the low nutritional state and to improve the dietary life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of masticatory ability by chewing gum test Measurement of tongue pressure by pressure measuring apparatus
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Group given chewing-gum Chewing-gum is given for 2 months, 3 times a day (breakfast, lunch, dinner), one piece a time.
Interventions/Control_2	Group not given chewing-gum Control group not chewing gum for 2 months
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	An elderly person over 65 years old living at home. He (She) can have a meal by oneself and can chew gums.
Key exclusion criteria	A person who have a medical history of systemic disease and severe mental illness A person who can not understand explanation to acquire informed consent A case that a principal investigator assesses unsuitability for examination
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazumune Middle name Last name Arikawa
Organization	Nihon University School of Dentistry at Matsudo.
Division name	Department of Community Oral Health
Zip code	271-8587
Address	870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL	047-360-9353
Email	arikawa.kazumune@nihon-u.ac.jp

Public contact
Name of contact person	1st name Kazumune Middle name Last name Arikawa
Organization	Nihon University School of Dentistry at Matsudo.
Division name	Department of Community Oral Health
Zip code	271-8587
Address	870-1 Sakaecho, Nishi-2, Matsudo, Chiba
TEL	047-360-9353
Homepage URL
Email	arikawa.kazumune@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Dentistry at Matsudo.
Institute
Department

Funding Source
Organization	Nihon University School of Dentistry at Matsudo.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University School of Dentistry at Matsudo.
Address	870-1 Sakaecho, Nishi-2, Matsudo, Chiba
Tel	047-360-9353
Email	arikawa.kazumune@nihon-u.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	2020 Year 06 Month 18 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	100
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	No longer recruiting
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2019 Year 11 Month 28 Day
Anticipated trial start date	2019 Year 12 Month 15 Day
Last follow-up date	2020 Year 07 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	2020 Year 06 Month 18 Day
Last modified on	2020 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046502