MIND Diet for Brain and Heart Health

Overseen By Naiman Khan, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Must not be taking: Oral hypoglycemics, Insulin

Disqualifiers: Liver disease, Gastrointestinal disease, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison.

The main questions it aims to answer are:

Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial?

Participants will:

Consume one meal that follows the MIND diet or a control meal every day for 3 months. Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking oral hypoglycemic agents or insulin. It might be best to discuss your specific medications with the trial coordinators.

Is the MIND diet safe for humans?

The MIND diet, which combines elements of the Mediterranean and DASH diets, has been studied for its potential benefits on brain health and cognitive performance. While specific safety data is limited, these diets are generally considered safe and are associated with positive health outcomes. ^{1 2 3 4 5}

How is the MIND Diet treatment different from other treatments for brain and heart health?

The MIND Diet is unique because it combines elements of the Mediterranean diet and the DASH diet, specifically focusing on foods that may reduce the risk of dementia and cognitive decline. Unlike other treatments, it emphasizes a dietary approach to potentially protect brain health and improve cognitive performance. ^{1 2 3 4 5}

What data supports the effectiveness of the MIND Diet treatment for brain and heart health?

Research shows that the MIND diet, which combines elements of the Mediterranean and DASH diets, is linked to better brain function and a lower risk of dementia. It also appears to reduce the risk of death from heart-related issues in people with heart disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Naiman Khan, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Are You a Good Fit for This Trial?

This trial is for middle-aged adults interested in improving brain and heart health through diet. Participants should be willing to consume a specific meal daily for 3 months and visit the lab for tests. There's no mention of specific exclusions, so generally healthy individuals may apply.

Inclusion Criteria

Able to consume the study meals

20/20 or corrected vision

No food allergies or intolerances

Exclusion Criteria

Food allergies or intolerances

Unable to consume the study meals

Non-consent of participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume one meal that follows the MIND diet or a control meal every day for 3 months. They also complete online forms and attend 4 in-person lab visits for tests.

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Diet
• MIND Diet

Trial Overview The OPTIMAL study is testing whether the MIND diet can boost cognitive performance and heart health compared to a standard healthy diet. It involves three groups: one selected by predictive analytics, another following the MIND diet without selection, and a control group on a regular healthy diet.

How Is the Trial Designed?

Group I: Standard MIND diet Experimental Treatment 1 Intervention

Participants in the active MIND diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. This will be a standard treatment arm without prior selection through predictive analytics. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.

Group II: Predictive Analytics informed MIND Diet Experimental Treatment 1 Intervention

Participants in the active MIND diet group informed by predictive analytics will be pre-identified based on the results of a machine learning model that predicts who will most likely benefit from the MIND diet. The participants in this group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The treatment meals will follow MIND diet guidelines and include leafy green vegetables, nuts, legumes, whole grains, berries, and extra virgin olive oil.

Group III: Control Diet Active Control 1 Intervention

Participants in the control diet group will be asked to consume one ready-to-eat meal per day from Daily Harvest® meal delivery service. The Control group will receive daily meals that are isocaloric with the active/experimental meals but will follow a general diet based on the average American diet and Dietary Guidelines for Americans (i.e., vegetables, fruits, nuts, whole grains, and unsaturated fats).

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Published Research Related to This Trial

In a study of 943 patients with atherosclerotic cardiovascular disease (ASCVD) or stroke, those who adhered more closely to the MIND diet had a significantly lower risk of all-cause and cardiovascular (CV) death compared to those with lower adherence.

For each one-point increase in MIND diet score, there was a 10% reduction in all-cause mortality risk and a 16% reduction in CV mortality risk, highlighting the potential benefits of the MIND diet for improving health outcomes in patients with ASCVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better adherence to the MIND diet is associated with lower risk of all-cause death and cardiovascular death in patients with atherosclerotic cardiovascular disease or stroke: a cohort study from NHANES analysis. Song, Y., Chang, Z., Jia, L., et al.[2023]

The MIND diet shows promise as a long-term treatment option for improving cognitive function in individuals with various forms of dementia, based on a systematic review of 11 studies involving different dementia pathologies.

All studies reviewed indicated a positive correlation between adherence to the MIND diet and cognitive functioning, although the effects on specific cognitive domains varied, highlighting the need for further research to understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the MIND Diet on Cognition in Individuals with Dementia. Healy, E.[2023]

Adherence to the MIND diet is associated with a significantly reduced risk of developing multiple sclerosis (MS), with an adjusted odds ratio of 0.10, indicating a strong protective effect based on a study of 77 patients with relapsing-remitting MS and 148 healthy controls.

Specific components of the MIND diet, such as high consumption of green leafy vegetables, other vegetables, and beans, are linked to lower odds of MS, while higher intake of unhealthy foods like pastries, sweets, and fried foods is associated with increased odds of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. Noormohammadi, M., Ghorbani, Z., Naser Moghadasi, A., et al.[2022]

In a study of 2,092 participants from the Framingham Heart Study, adherence to the MIND diet was linked to better cognitive function and larger total brain volume, suggesting potential protective effects against cognitive decline.

However, the MIND diet did not show a significant association with measures of brain atrophy or silent brain infarcts, indicating that while it may support cognitive health, its impact on preventing brain structure changes remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind Diet Adherence and Cognitive Performance in the Framingham Heart Study. Melo van Lent, D., O'Donnell, A., Beiser, AS., et al.[2021]

In a 3-year randomized controlled trial involving 604 older adults at risk for dementia, the MIND diet did not show significant cognitive benefits compared to a control diet, with only a slight improvement in global cognition scores for the MIND diet group.

MRI results indicated no significant differences in brain characteristics, such as white-matter hyperintensities and hippocampal volumes, between participants following the MIND diet and those on the control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. Barnes, LL., Dhana, K., Liu, X., et al.[2023]

In a study of 2,598 older adults, those who adhered more closely to the MIND dietary pattern showed significantly better cognitive performance, particularly in tests related to memory and global cognition.

While both MIND and Mediterranean-like diets were associated with improved cognitive scores, the MIND diet demonstrated stronger positive correlations with cognitive performance compared to the Mediterranean Eating Pattern for Americans (MEPA III).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive performance in relation to MIND and MEPA III dietary pattern accordance of NHANES participants. Derdiger, S., Friedeborn, S., Tangney, CC.[2023]

In a study of 882 older adults over 12 years, adherence to the MIND diet was linked to a 12% reduction in all-cause mortality risk for each unit increase in diet score, indicating its potential health benefits.

Participants with the highest adherence to the MIND diet had a 37% lower risk of death compared to those with the lowest adherence, suggesting that this dietary pattern may be a valuable public health recommendation for increasing longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the MIND diet is associated with 12-year all-cause mortality in older adults. Corley, J.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive performance in relation to MIND and MEPA III dietary pattern accordance of NHANES participants. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of the MIND Diet on Cognition in Individuals with Dementia. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Better adherence to the MIND diet is associated with lower risk of all-cause death and cardiovascular death in patients with atherosclerotic cardiovascular disease or stroke: a cohort study from NHANES analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adherence to the MIND diet is associated with 12-year all-cause mortality in older adults. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mind Diet Adherence and Cognitive Performance in the Framingham Heart Study. [2021]