MIND Diet and Cognitive Function in Middle-aged and Older Adults

NCT ID: NCT06417749

Last Updated: 2024-05-16

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2025-10-10

Brief Summary

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A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.

Detailed Description

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Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet education will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legumes, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.

Conditions

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Cognitive Function Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two-arm parallel design, with one arm being the control arm and the other being the intervention arm (MIND diet education and food supply).
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
This is a single-blind design, where the outcome assessors will be masked from the assignment of the participants.

Study Groups

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Control arm

General dietary advice

Group Type PLACEBO_COMPARATOR

Control arm

Intervention Type BEHAVIORAL

Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.

Intervention arm

MIND diet education

Group Type ACTIVE_COMPARATOR

Intervention arm

Intervention Type BEHAVIORAL

Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up.

Interventions

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Control arm

Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.

Intervention Type BEHAVIORAL

Intervention arm

Participants will be given three MIND diet education videos on different topics at baseline and during follow-up. In addition, each participant will receive a MIND diet education brochure at baseline and some food supply during follow-up.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Normal chewing function, able to eat hard foods such as nuts.
* Willing to participate and sign an informed consent form.
* Able to understand research procedures and adhere to them throughout the entire study period.

Exclusion Criteria

* Participation in or have participated in other clinical trial studies within the past year.
* Medication to treat Alzheimer's or Parkinson's disease.
* Diagnosis of severe chronic diseases, such as cancer.
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Changzheng Yuan

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mutiple Counties

Taian, Shandong, China

Site Status

Countries

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China

Facility Contacts

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Changzheng Yuan, ScD

Role: primary

(86)17326860291

Other Identifiers

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LL20240353

Identifier Type: -

Identifier Source: org_study_id

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