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Completed

NCT Number: NCT04383704

MIND Diet Intervention and Cognitive Performance

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shiraz University of Medical Science

Shiraz, Fars, 71345-1978, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: MIND

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 12, 2020
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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