NCT04383704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 5, 2020

Last Update Submit

May 7, 2020

Conditions

Obesity

Outcome Measures

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.

    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 Outcomes (1)

  • 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 Arms (2)

calorie-restricted modified MIND diet

EXPERIMENTAL

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))

calorie-restricted standard control diet

ACTIVE COMPARATOR

They instructed to calorie-restricted diet alone.

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

Interventions

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.

calorie-restricted modified MIND dietcalorie-restricted standard control diet

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Science

Shiraz, Fars, 71345-1978, Iran

Location

Related Publications (1)

  • Arjmand G, Abbas-Zadeh M, Eftekhari MH. Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: a randomized controlled trial. Sci Rep. 2022 Feb 21;12(1):2871. doi: 10.1038/s41598-021-04258-9.

    PMID: 35190536DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD. professor of clinical nutrition (clinical nutrition, school of nutrition and food science)

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 12, 2020

Study Start

October 26, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

IR(1)