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Clinical Trials/NCT04383704
NCT04383704CompletedNot Applicable

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

Shiraz University of Medical Sciences1 site in 1 country37 target enrollmentStarted: October 26, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
37
Locations
1
Primary Endpoint
Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

calorie-restricted modified MIND diet

Experimental

This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines.

Intervention: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) (Other)

calorie-restricted standard control diet

Active Comparator

They instructed to calorie-restricted diet alone.

Intervention: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammad Hassan Eftekhari

PHD. professor of clinical nutrition (clinical nutrition, school of nutrition and food science)

Shiraz University of Medical Sciences

Study Sites (1)

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