MIND Diet Intervention and Cognitive Performance

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04383704

Collaborator

(none)

Enrollment

Location

Arms

4.8

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 26, 2018

Actual Primary Completion Date :

Mar 20, 2019

Actual Study Completion Date :

Mar 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: calorie-restricted modified MIND diet This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines.	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.
Active Comparator: calorie-restricted standard control diet They instructed to calorie-restricted diet alone.	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.

Arm

Intervention/Treatment

Experimental: calorie-restricted modified MIND diet

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

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.

Active Comparator: calorie-restricted standard control diet

They instructed to calorie-restricted diet alone.

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiraz University of Medical Science	Shiraz	Fars	Iran, Islamic Republic of	71345-1978

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Hassan Eftekhari, PHD. professor of clinical nutrition (clinical nutrition, school of nutrition and food science), Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT04383704

Other Study ID Numbers:

IR.SUMS.REC.1397.759

First Posted:

May 12, 2020

Last Update Posted:

May 12, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 12, 2020