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Completed

NCT Number: NCT05865340

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

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mediterranean Diet Mental Disorders Neurocognitive Disorders Oral Health

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

oral health + MED diet

Behavioral

oral health + MED diet education

oral health

Behavioral

oral health education

MED diet

Behavioral

MED diet education

Primary outcomes

  1. cognitive

    Time frame: 6 months

    MoCA&MMSE

  2. diet

    Time frame: 6 months

    MEDAS-14 item

  3. oral health

    Time frame: 6 months

    OHAT

  4. frailty

    Time frame: 6 months

    Frailty Criteria

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • National Yang Ming Chiao Tung University

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 18, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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