Chewing Gum and Cognitive Function

NCT05873023 | Unknown DMC

• 1 other identifier: 202105034
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

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.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of global cognition

  Change from Baseline at 12 weeks

• Change of function

  Change from Baseline at 12 weeks

• Change of depression

  Change from Baseline at 12 weeks

• Change of activities of daily living

  Change from Baseline at 12 weeks

• Change of quality of life

  Change from Baseline at 12 weeks

Other Outcomes (1)

• Change of cortical thickness and brain network function

  Change from Baseline at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

The control group does not participate in chewing gum.

Interventions

Chewing gum OTHER

chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.

Intervention

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead
• Bobath Memorial Hospital: collaborator

Study Sites (4)

Bobath Memorial Hospital

Seongnam-si, Gyeonggi-do, 13552, South Korea

RECRUITING

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Ewha Womans Seoul Hospital

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hae Ri Na, MD, PhD

  Bobath Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Hye Choi, MD, PhD

CONTACT

82 32 8902947; seonghye@inha.ac.kr

Hae Ri Na, MD, PhD

CONTACT

neuna102@paran.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: October 17, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 29, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 2 years since March 2025.
• Access Criteria: Reasonable request

Locations

KR (4)