MIND Diet Intervention and Cognitive Performance

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))

• Registration Number: NCT04383704
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-26
• Primary Completion: 2019-03-20
• Study Completion: 2019-03-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calorie-restricted modified MIND diet	New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))	This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines.
calorie-restricted standard control diet	New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))	They instructed to calorie-restricted diet alone.

Primary Outcome Measures

Name	Time	Method
Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of changes in brain structures measured by Magnetic Resonance Imaging (MRI) baseline and after three months follow up.	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.

Trial Locations

Locations (1)

Shiraz University of Medical Science; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of