Chewing Gum and Cognitive Function

Effect of Chewing Gum on Cognitive Function

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Other: Chewing gum

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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hae Ri Na, MD, PhD; Email: neuna102@paran.com
• Study Contact Backup: Name: Seong Hye Choi, MD, PhD; Phone Number: 82 32 8902947; Email: seonghye@inha.ac.kr

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Recruiting
    • Inha University Hospital
    • Contact: Seong Hye Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Womans Seoul Hospital
    • Contact: Jee Hyang Jeong, MD, PhD
  • Suwon, Korea, Republic of
    • Recruiting
    • Ajou University Hospital
    • Contact: So Young Moon, MD, PhD
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13552
      • Recruiting
      • Bobath Memorial Hospital
      • Contact: Hae Ri Na, MD, PhD; Email: neuna102@paran.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Chewing gum; chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.
No Intervention: Control; The control group does not participate in chewing gum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.	Change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of global cognition	Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance.	Change from Baseline at 12 weeks
Change of function	Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.	Change from Baseline at 12 weeks
Change of depression	Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood.	Change from Baseline at 12 weeks
Change of activities of daily living	Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.	Change from Baseline at 12 weeks
Change of quality of life	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.	Change from Baseline at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cortical thickness and brain network function	brain MRI (3D-T1 weighted images and resting state functional MRI)	Change from Baseline at 12 weeks

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Collaborators: Bobath Memorial Hospital
• Investigators: Principal Investigator: Hae Ri Na, MD, PhD, Bobath Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): December 29, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 202105034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No