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To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment (MCI), Oral Health, Mediterranean Diet

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oral health + MED diet
oral health
MED diet
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment (MCI)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Over or equal to 50 years old CDR score is less than or equal to 0.5 or MMSE score is 24-30 (including 24 and 30) Conscious/complaint of cognitive decline Exclusion Criteria: Dementia Acute and significant mental illness in the past three months Acute serious medical and surgical diseases in the past three months Symptoms of delusions, hallucinations or delirium in the past three months Severe visual and hearing impairment in the past three months Other conditions that make the patient unable to cooperate: such as not being suitable after screening, not signing the subject's consent form.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

No Intervention

Arm Label

oral health + MED diet

oral health

MED diet

compare

Arm Description

oral health + MED diet education

oral health education

MED diet education

Outcomes

Primary Outcome Measures

cognitive
MoCA&MMSE
diet
MEDAS-14 item
oral health
OHAT
frailty
Frailty Criteria

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
May 9, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming Chiao Tung University
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1. Study Identification

Unique Protocol Identification Number
NCT05865340
Brief Title
To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment
Official Title
To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming Chiao Tung University

4. Oversight

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

5. Study Description

Brief Summary
At present, many literatures have confirmed that the Mediterranean diet has the effect of delaying cognitive degeneration in patients with mild cognitive impairment, and can also slow down the speed of brain atrophy. In addition to the highly respected Mediterranean diet every year, several years of foreign research have found The maintenance of oral hygiene also has a significant relationship with the decline of cognitive function. The intervention of "oral hygiene" is a new intervention method that has started in recent years. Oral health will affect the overall health status, physical function, diet and nutritional status of the elderly. In particular, older adults with poor oral health are more likely to suffer from mild cognitive impairment. The relationship between oral health and nutrition and overall health is inseparable. If the concept of healthy eating (Mediterranean diet) recognized by the public is used and oral health education is involved at the same time. To allow patients with mild cognitive impairment to maintain oral health care in daily life, and to increase the knowledge of the Mediterranean diet and try to follow the rules of the Mediterranean diet, whether there is a more significant impact on these patients.
Detailed Description
This trial is expected to enroll 120 subjects, which will be accepted by the relevant researchers who carry out this study. In the pre-test part, all subjects will receive the Montreal Intelligence Test (MoCA) and Mini Intelligence Examination (MMSE) and collect MEDAS-14 Item, Oral Health Assessment Tool, OHAT and evaluation data of Taiwan Frailty Criteria of Taiwan. After completing the 12-week oral health and Mediterranean diet education intervention, all subjects will undergo post-test follow-up evaluation (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria), and all subjects will be assessed 12 weeks after the intervention The subjects were followed up with follow-up cognitive function tracking (MoCA, MMSE, MEDAS-14 item, OHAT and Frailty Criteria). Finally, all the data were statistically analyzed to study which of the individual measures and the combined measures had a more significant cognitive effect on MCI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI), Oral Health, Mediterranean Diet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral health + MED diet
Arm Type
Other
Arm Description
oral health + MED diet education
Arm Title
oral health
Arm Type
Other
Arm Description
oral health education
Arm Title
MED diet
Arm Type
Other
Arm Description
MED diet education
Arm Title
compare
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
oral health + MED diet
Intervention Description
oral health + MED diet education
Intervention Type
Behavioral
Intervention Name(s)
oral health
Intervention Description
oral health education
Intervention Type
Behavioral
Intervention Name(s)
MED diet
Intervention Description
MED diet education
Primary Outcome Measure Information:
Title
cognitive
Description
MoCA&MMSE
Time Frame
6 months
Title
diet
Description
MEDAS-14 item
Time Frame
6 months
Title
oral health
Description
OHAT
Time Frame
6 months
Title
frailty
Description
Frailty Criteria
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over or equal to 50 years old CDR score is less than or equal to 0.5 or MMSE score is 24-30 (including 24 and 30) Conscious/complaint of cognitive decline Exclusion Criteria: Dementia Acute and significant mental illness in the past three months Acute serious medical and surgical diseases in the past three months Symptoms of delusions, hallucinations or delirium in the past three months Severe visual and hearing impairment in the past three months Other conditions that make the patient unable to cooperate: such as not being suitable after screening, not signing the subject's consent form.
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei Ning Wang
Phone
+886228712121#86763
Email
linda2860@gmail.com
First Name & Middle Initial & Last Name & Degree
Jou Chun Lin
Phone
+886916015422
Email
jouchunwork@gmail.com
First Name & Middle Initial & Last Name & Degree
Pei Ning Wang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment

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