Effect of MIND Diet Intervention on Cognitive Function in Adults With Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Zhejiang University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To examine the effects of a 1-year cluster-randomized controlled intervention of MIND diet on cognitive function among 240 participants with mild cognitive function (MCI) aged 50 years and above from 4 communities.
Detailed Description
The current study is a 1-year cluster-randomized controlled intervention trial designed to examine whether the a localized modified Mediterranean-Dietary Approaches to Stop Hypertension (DASH) dietary intervention for neurodegenerative delay (MIND) diet will improve cognitive function among 240 participants with MCI from 4 communities. The modified MIND diet recommends 11 brain healthy food groups (green leafy vegetables, dark red and yellow vegetables, other vegetables, nuts, berries, beans, whole grains, seafood, poultry, olive/tea-seed oil and green tea) and limits intake of 4 unhealthy food groups (red meat and products, animal oil, pastries and sweets, and fried/fast food). This study will randomly assign 240 MCI participants to two groups: A) MIND diet intervention group and B) control group, and estimate the cognitive and biological impacts of the 1-year intervention.
Investigators
Changzheng Yuan
Professor
Zhejiang University
Eligibility Criteria
Inclusion Criteria
- •At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8\>=3 and/or 5-min MoCA \< 11)
- •Free of physical disabilities that preclude participation in the study
- •Willing to complete all study-related activities for 24 months
- •Willing to be randomized to either intervention group
Exclusion Criteria
- •Allergic to more than one type of food (nuts, berries, olive oil, or fish)
- •Diagnosed of dementia, severe diabetes mellitus, cardiovascular disease, cancer, thyroid disease, kidney disease, or liver disease
- •Diagnosed of major depression or other neuropsychological diseases
- •Severe loss of vision, hearing or communicative ability
- •Substance abuse within 6 months or heavy alcohol consumption (\> 2 drinks/day for women; \> 3 drinks/day for men).
Outcomes
Primary Outcomes
Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)
Time Frame: Up to one year
Global cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB). The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.
Change in Domain-specific Cognition
Time Frame: Up to one year
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction. The z-score calculation will use the population mean and standard deviation, and a higher z-score indicates better cognitive performance.
Secondary Outcomes
- Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)(Up to one year)
- Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)(Up to one year)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Up to one year)
- Change in Montreal Cognitive Assessment (MoCA) score(Up to one year)