MIND Diet and Cognitive Function in Adults With MCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Cognitive Function Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Single (outcomes assessor)

Study Groups

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MIND diet intervention

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.

Group Type EXPERIMENTAL

MIND diet education

Intervention Type BEHAVIORAL

An intensified education program following a localized modified MIND diet for 1 year, which 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).

Routine follow-up and general advice

Intervention Type BEHAVIORAL

Routine follow-up administered by trained staff.

Control group

Participants in the control group will be routinely followed up and given general advice on healthy lifestyle.

Group Type ACTIVE_COMPARATOR

Routine follow-up and general advice

Intervention Type BEHAVIORAL

Routine follow-up administered by trained staff.

Interventions

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MIND diet education

An intensified education program following a localized modified MIND diet for 1 year, which 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).

Intervention Type BEHAVIORAL

Routine follow-up and general advice

Routine follow-up administered by trained staff.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No