MIND Diet and Cognitive Function in Adults With MCI

Not Applicable

Recruiting

• Conditions: Cognitive Function; Mild Cognitive Impairment; Cognitive Decline
• Interventions: Behavioral: MIND diet education; Behavioral: Routine follow-up and general advice

• Registration Number: NCT05975723
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study Start: 2023-07-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIND diet intervention	MIND diet education	Participants in the MIND diet group will receive an education program on a localized MIND diet for 1-year, and will be routinely followed up and given advice on other healthy lifestyles.
MIND diet intervention	Routine follow-up and general advice	Participants in the MIND diet group will receive an education program on a localized MIND diet for 1-year, and will be routinely followed up and given advice on other healthy lifestyles.
Control group	Routine follow-up and general advice	Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.

Primary Outcome Measures

Name	Time	Method
Change in Global Cognition measured by comprehensive Neuropsychological Test Battery (NTB)	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	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 Outcome Measures

Name	Time	Method
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	The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.
Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)	Up to one year	The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Change in Pittsburgh Sleep Quality Index (PSQI)	Up to one year	The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Change in Montreal Cognitive Assessment (MoCA) score	Up to one year	MoCA will be assessed to determine cognitive change.

Trial Locations

Locations (1)

Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China