MIND Diet and Cognitive Function in Adults With MCI

Zhejiang University

Status: Enrolling

Conditions: Cognitive Function; Mild Cognitive Impairment; Cognitive Decline

Treatments: Behavioral: Routine follow-up and general advice; Behavioral: MIND diet education

Study type: Interventional

Funder types: Other

Identifiers

NCT05975723

AARG-22-928604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

MIND diet intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Routine follow-up and general advice

Behavioral: MIND diet education

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Routine follow-up and general advice