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

May 12, 2024 updated by: Changzheng Yuan, Zhejiang University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Taian, Shandong, China, 271000
        • Mutiple Counties
        • Principal Investigator:
          • Changzheng Yuan, ScD
        • Contact:
        • Sub-Investigator:
          • Tao Zhang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control arm
General dietary advice
Behavioral: Control arm
Participants will receive a copy of the Chinese Dietary Guidelines leaflet at baseline.
Active Comparator: Intervention arm
MIND diet education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 5-min Montreal Cognitive Assessment (MoCA) score
Time Frame: 12 months
Cognitive function will be assessed using the MoCA at baseline and during follow-up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EuroQol Five Dimensions (EQ-5D) scale
Time Frame: 12 months
The 5-level EQ-5D (EQ-5D-5L) will be used to assess life quality. Evaluations will be conducted at baseline and during follow-up.
12 months
Change in 8-Item Alzheimer's Diseases Screening Tool (AD-8) score
Time Frame: 12 months
AD-8 will be used to assess cognitive function. Evaluations will be conducted at baseline and during follow-up.
12 months
Change in Mediterranean-Dietary Approach to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet score
Time Frame: 12 months
Dietary behavior will be assessed using food frequency questionnaire (FFQ). A 15-point MIND diet score will be calculated to reflect the MIND diet adherence among both groups of participants. Evaluations will be conducted at baseline and during follow-up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2024

Primary Completion (Estimated)

May 10, 2025

Study Completion (Estimated)

October 10, 2025

Study Registration Dates

First Submitted

May 12, 2024

First Submitted That Met QC Criteria

May 12, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL20240353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Interested collaborators may put in a request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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