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Clinical Trials/NCT04383704
NCT04383704
Completed
Not 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 enrollmentOctober 26, 2018
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Shiraz University of Medical Sciences
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.
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 26, 2018
End Date
March 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Eligibility Criteria

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.

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.)

Study Sites (1)

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