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

NCT05865340 | Completed

• 1 other identifier: 2022-12-013BCF
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• cognitive

  MoCA\&MMSE

  6 months

• diet

  MEDAS-14 item

  6 months

• oral health

  OHAT

  6 months

• frailty

  Frailty Criteria

  6 months

Study Arms (4)

oral health + MED diet

OTHER

oral health + MED diet education

Behavioral: oral health + MED diet

oral health

OTHER

oral health education

Behavioral: oral health

MED diet

OTHER

MED diet education

Behavioral: MED diet

compare

NO INTERVENTION

Interventions

oral health + MED diet BEHAVIORAL

oral health + MED diet education

oral health + MED diet

oral health BEHAVIORAL

oral health education

oral health

MED diet BEHAVIORAL

MED diet education

MED diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 18, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)