ObesityMINDNCT04383704
MIND Diet Intervention and Cognitive Performance
A study testing New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) in people with Obesity, run by Shiraz University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIran
- Study dates
- 26 Oct 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial
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.
- Conditions
- Obesity
- Being tested
- New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| calorie-restricted modified MIND diet | Experimental | This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines. Receives: 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. Receives: Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Magnetic Resonance Imaging (MRI) was carried out to quantify the differences in brain structure changes baseline, and after three months follow up.
Measured: Baseline and after three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start26 Oct 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hassan Eftekhari, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383704
- Sponsor's protocol ID
- IR.SUMS.REC.1397.759
- Acronym
- MIND
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35190536
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04383704
- Acronym / sponsor ID
- MIND / IR.SUMS.REC.1397.759
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calorie-restricted modified MIND diet | Experimental | Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))This arm received instruction in modifying the content of their diet to meet MIND pattern guidelines. |
| calorie-restricted standard control diet | Active comparator | Other: New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))They instructed to calorie-restricted diet alone. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | calorie-restricted modified MIND diet, calorie-restricted standard control diet |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 35190536Arjmand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)) in people with Obesity, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.