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

NCT ID: NCT05865340

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

oral health + MED diet

oral health + MED diet education

Group Type: OTHER

oral health + MED diet

Intervention Type: BEHAVIORAL

oral health + MED diet education

oral health

oral health education

Group Type: OTHER

oral health

Intervention Type: BEHAVIORAL

oral health education

MED diet

MED diet education

Group Type: OTHER

MED diet

Intervention Type: BEHAVIORAL

MED diet education

compare

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

oral health + MED diet

oral health + MED diet education

Intervention Type: BEHAVIORAL

oral health

oral health education

Intervention Type: BEHAVIORAL

MED diet

MED diet education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Over or equal to 50 years old

2. CDR score is less than or equal to 0.5 or MMSE score is 24-30 (including 24 and 30)

3. Conscious/complaint of cognitive decline

Exclusion Criteria

1. Dementia

2. Acute and significant mental illness in the past three months

3. Acute serious medical and surgical diseases in the past three months

4. Symptoms of delusions, hallucinations or delirium in the past three months

5. Severe visual and hearing impairment in the past three months

6. Other conditions that make the patient unable to cooperate: such as not being suitable after screening, not signing the subject's consent form.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2022-12-013BCF

Identifier Type: -

Identifier Source: org_study_id