MIND Diet Intervention and Cognitive Performance

Obesity Clinical Trial

— MIND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383704
• Other study ID #: IR.SUMS.REC.1397.759
• Status: Completed
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: May 2020
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Science	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.	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	Assessment of changes in brain structures measured by Magnetic Resonance Imaging (MRI) baseline and after three months follow up.	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.