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

Not Applicable

Completed

• Conditions: Oral Health; Mediterranean Diet; Mild Cognitive Impairment (MCI)
• Interventions: Behavioral: oral health + MED diet; Behavioral: MED diet; Behavioral: oral health

• Registration Number: NCT05865340
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-05-09
• Study Start: 2023-05-15
• Study First Posted: 2023-05-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral health + MED diet	oral health + MED diet	oral health + MED diet education
MED diet	MED diet	MED diet education
oral health	oral health	oral health education

Primary Outcome Measures

Name	Time	Method
diet	6 months	MEDAS-14 item
oral health	6 months	OHAT
cognitive	6 months	MoCA\&MMSE
frailty	6 months	Frailty Criteria

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan