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

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05865340
• Collaborator: National Yang Ming Chiao Tung University (Other)
• Enrollment: 120
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 7.6
• Patients Per Site Per Month: 15.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment (MCI); Oral Health; Mediterranean Diet	Behavioral: oral health + MED diet; Behavioral: oral health; Behavioral: MED diet	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: To Exam the Efficacy of Oral Health and Mediterranean Diet Interventions in Preventing Cognitive Decline Among Older Adults With Mild Cognitive Impairment
• Anticipated Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: oral health + MED diet oral health + MED diet education	Behavioral: oral health + MED diet; oral health + MED diet education
Other: oral health oral health education	Behavioral: oral health; oral health education
Other: MED diet MED diet education	Behavioral: MED diet; MED diet education
No Intervention: compare

Outcome Measures

Primary Outcome Measures

1. cognitive [6 months]

   MoCA&MMSE

2. diet [6 months]

   MEDAS-14 item

3. oral health [6 months]

   OHAT

4. frailty [6 months]

   Frailty Criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan
• National Yang Ming Chiao Tung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT05865340
• Other Study ID Numbers: 2022-12-013BCF
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of May 18, 2023