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Chewing Gum and Cognitive Function

Primary Purpose

Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chewing gum
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 60 to 79 years of age All posterior teeth are evenly occluded on both sides, and those who have lost 4 or less teeth in the posterior teeth Those who scored 50 points or less on the periodontal disease self-checklist Meet the diagnostic criteria for subjective cognitive decline or mild cognitive impairment Provide written informed consent Exclusion Criteria: Those who have difficulty in chewing due to toothache, periodontal disease, temporomandibular joint disease, severe malocclusion, shaking teeth, etc. Those who wear dentures on the upper or lower teeth Dementia Major psychiatric illness such as major depressive disorders Other neurodegenerative disease (e.g., Parkinson's disease) Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease, or any medical conditions preventing to complete the study as judged by the study physician Severe loss of vision, hearing, or communicative disability Significant laboratory abnormality that may result in cognitive impairment Any conditions preventing cooperation as judged by the study physician Coincident participation in any other intervention trial Those who are planning dental treatment such as preservation, prosthetics, and implants during the research period

Sites / Locations

  • Bobath Memorial HospitalRecruiting
  • Inha University HospitalRecruiting
  • Ewha Womans Seoul HospitalRecruiting
  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The intervention group chew one unscented gum provided by the study for 12 weeks. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting a proof photo in the KakaoTalk chat room.

The control group does not participate in chewing gum.

Outcomes

Primary Outcome Measures

Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.

Secondary Outcome Measures

Change of global cognition
Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance.
Change of function
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change of depression
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood.
Change of activities of daily living
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change of quality of life
Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.

Full Information

First Posted
May 15, 2023
Last Updated
May 15, 2023
Sponsor
Inha University Hospital
Collaborators
Bobath Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05873023
Brief Title
Chewing Gum and Cognitive Function
Official Title
Effect of Chewing Gum on Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inha University Hospital
Collaborators
Bobath Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to investigate whether the improvement or maintenance of cognitive function is superior to the control group when gum chewing is performed in elderly people with subjective cognitive decline or mild cognitive impairment.
Detailed Description
The intervention group chew one unscented gum provided by the study for 12 weeks. Using KakaoTalk, the coordinator sends a chewing gum alarm. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting an authentication photo in the KakaoTalk chat room. The research coordinator checks the certification on a weekly basis and sends a separate phone call to encourage participants who do not chew gum more than twice a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention group chew one unscented gum provided by the study for 12 weeks. The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side. After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting a proof photo in the KakaoTalk chat room.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group does not participate in chewing gum.
Intervention Type
Other
Intervention Name(s)
Chewing gum
Intervention Description
chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.
Primary Outcome Measure Information:
Title
Change of cognition
Description
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
Time Frame
Change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Change of global cognition
Description
Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance.
Time Frame
Change from Baseline at 12 weeks
Title
Change of function
Description
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 12 weeks
Title
Change of depression
Description
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood.
Time Frame
Change from Baseline at 12 weeks
Title
Change of activities of daily living
Description
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 12 weeks
Title
Change of quality of life
Description
Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Time Frame
Change from Baseline at 12 weeks
Other Pre-specified Outcome Measures:
Title
Change of cortical thickness and brain network function
Description
brain MRI (3D-T1 weighted images and resting state functional MRI)
Time Frame
Change from Baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 to 79 years of age All posterior teeth are evenly occluded on both sides, and those who have lost 4 or less teeth in the posterior teeth Those who scored 50 points or less on the periodontal disease self-checklist Meet the diagnostic criteria for subjective cognitive decline or mild cognitive impairment Provide written informed consent Exclusion Criteria: Those who have difficulty in chewing due to toothache, periodontal disease, temporomandibular joint disease, severe malocclusion, shaking teeth, etc. Those who wear dentures on the upper or lower teeth Dementia Major psychiatric illness such as major depressive disorders Other neurodegenerative disease (e.g., Parkinson's disease) Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease, or any medical conditions preventing to complete the study as judged by the study physician Severe loss of vision, hearing, or communicative disability Significant laboratory abnormality that may result in cognitive impairment Any conditions preventing cooperation as judged by the study physician Coincident participation in any other intervention trial Those who are planning dental treatment such as preservation, prosthetics, and implants during the research period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Hye Choi, MD, PhD
Phone
82 32 8902947
Email
seonghye@inha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hae Ri Na, MD, PhD
Email
neuna102@paran.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hae Ri Na, MD, PhD
Organizational Affiliation
Bobath Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bobath Memorial Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13552
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae Ri Na, MD, PhD
Email
neuna102@paran.com
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Hye Choi, MD
Facility Name
Ewha Womans Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Hyang Jeong, MD, PhD
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Young Moon, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study will be available from the principal investigator upon reasonable request.
IPD Sharing Time Frame
Data will be available for 2 years since March 2025.
IPD Sharing Access Criteria
Reasonable request

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Chewing Gum and Cognitive Function

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