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

Oral Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865340
• Other study ID #: 2022-12-013BCF
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mediterranean Diet
• Mild Cognitive Impairment (MCI)
• Oral Health

Intervention

Behavioral:
• oral health + MED diet
oral health + MED diet education
• oral health
oral health education
• MED diet
MED diet education

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming Chiao Tung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive	MoCA&MMSE	6 months
Primary	diet	MEDAS-14 item	6 months
Primary	oral health	OHAT	6 months
Primary	frailty	Frailty Criteria	6 months