Cognitive DysfunctionNCT05873023
Chewing Gum and Cognitive Function
A study testing Chewing gum in people with Cognitive Dysfunction, run by Inha University Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 17 Oct 2022to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Hae Ri Na, MD, PhD contact
South Korea4 sites, 4 recruiting
- Recruiting
Inha University Hospital
Incheon, 22332
Seong Hye Choi, MD
- Recruiting
Bobath Memorial Hospital
Seongnam-si, Gyeonggi-do, 13552
Hae Ri Na, MD, PhD, neuna102@paran.com
- Recruiting
Ewha Womans Seoul Hospital
Seoul
Jee Hyang Jeong, MD, PhD
- Recruiting
Ajou University Hospital
Suwon
So Young Moon, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- Chewing gum
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
chewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chewing gum |
| Control | No intervention | The control group does not participate in chewing gum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
Measured: Change from Baseline at 12 weeks
Secondary outcomes (5)
Change of global cognition
Korean Mini-Mental State Examination-2 (range, 0-30). Higher scores indicate better performance.
Measured: Change from Baseline at 12 weeks
Change of function
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Measured: Change from Baseline at 12 weeks
Change of depression
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse mood.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start17 Oct 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bobath Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Hae Ri Na, MD, PhD, Principal investigator, Bobath Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873023
- Sponsor's protocol ID
- 202105034
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chewing Gum on Cognitive Function
- ClinicalTrials.gov ID
- NCT05873023
- Acronym / sponsor ID
- 202105034
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Bobath Memorial Hospital
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Chewing gumThe 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. |
| Control | No intervention | –The control group does not participate in chewing gum. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing gumchewing gum everyday for 12 weeks. Alternate chewing for 10 minutes on the right and 10 minutes on the left. | Other | Intervention |
Primary outcome
Change of cognition
Time frame: Change from Baseline at 12 weeks
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
5 secondary outcomes
Change of global cognition
Time frame: Change from Baseline at 12 weeks
Change of function
Time frame: Change from Baseline at 12 weeks
Change of depression
Time frame: Change from Baseline at 12 weeks
Change of activities of daily living
Time frame: Change from Baseline at 12 weeks
Change of quality of life
Time frame: Change from Baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available from the principal investigator upon reasonable request.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hae Ri Na, MD, PhD contact
Hae Ri Na, MD, PhD principal investigator
Bobath Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum in people with Cognitive Dysfunction, run by Inha University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong Hye Choi, MD, PhD (82 32 8902947, seonghye@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cognition (time frame: Change from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.