MIND Diet Intervention and Cognitive Performance (MIND)

May 7, 2020 updated by: Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences

Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial

This single-center, randomized trial examined the effect of MIND diet intervention on cognition and brain structure changes of healthy obese women over three months. The intervention group was lea to calorie-restricted modified by the MIND diet, and the control group received a calorie-restricted standard diet. The primary end-point was an assessment of cognitive performances measured with a comprehensive cognitive test battery. Secondary end-points were voxel-based morphometry to quantify the differences in brain structures. Our results revealed MIND diet could improve working memory, verbal recognition memory, and attention, more in comparison with the control group. Results also suggest that an increase in inferior frontal gyrus in the MIND diet group. Our study, for the first time, underlined that good adherence to the MIND diet as well as calorie restriction could reverse the destructive effect of obesity on cognition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Middle-aged women (40-60 years),
  • Without any metabolic complication,
  • BMI 30-35 kg/m2,
  • MMSE ≥ 24,
  • And no history of severe untreated medical, neurological, and psychiatric diseases which may interfere with the study intervention.

Exclusion Criteria:

  • Have gastrointestinal problems,
  • Participate in weight loss programs,
  • Use weight loss drugs in the last three months,
  • Had not wholly followed the dietary pattern,
  • Became pregnant,
  • And undergo special medical treatments during a three months study.

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
Experimental: calorie-restricted modified MIND diet
This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines.
Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))
A new brain-protection pattern that has been designed after the Mediterranean and DASH diet to improve some of their dietary factors to have the highest impact on brain health and cognitive performance.
Active Comparator: calorie-restricted standard control diet
They instructed to calorie-restricted diet alone.
Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))
A new brain-protection pattern that has been designed after the Mediterranean and DASH diet to improve some of their dietary factors to have the highest impact on brain health and cognitive performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.
Time Frame: Baseline and after three months.
All of the participants were tested on a complex paper-based battery of neurocognitive tests to examine changes in cognitive performance in different domains at baseline and after three months follow up. These tests include Forward Digit Span Task (FDST), Backward Digit Span Task (BDST), Letter Number Sequencing Task (LNST), Symbol Digit Modality Task (SDMT), Auditory Verbal Learning Test (AVLT) and Stroop task.
Baseline and after three months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in brain structures measured by Magnetic Resonance Imaging (MRI) baseline and after three months follow up.
Time Frame: Baseline and after three months.
Magnetic Resonance Imaging (MRI) was carried out to quantify the differences in brain structure changes baseline, and after three months follow up.
Baseline and after three months.

Collaborators and Investigators

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

Sponsor

Shiraz University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 26, 2018

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

March 20, 2019

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IR.SUMS.REC.1397.759

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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