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?

This trial aims to determine if the MIND diet, which includes foods like leafy greens, nuts, and berries, can improve brain and heart health. It compares three groups: one selected by a model predicting who benefits most from the MIND diet, a second group following the MIND diet, and a third group on a regular healthy diet (Control Diet). Participants will consume a specific meal daily for three months and track their food intake. The trial seeks middle-aged adults without major health issues, such as liver or gastrointestinal diseases, and who are not on certain medications. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and health.

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.

What prior data suggests that the MIND diet is safe for improving brain and heart health?

Research has shown that the MIND diet, which combines elements of the Mediterranean and DASH diets, is generally safe and easy to follow. Studies have found that it emphasizes foods beneficial for brain health, such as leafy greens, nuts, and berries. No major negative effects have been reported from following this diet.

One study found that adherence to the MIND diet was linked to a lower risk of developing dementia and slower memory loss, with no major health problems reported. This suggests the diet is not only safe but may also benefit brain health.

Overall, current evidence supports the MIND diet as a safe option for those seeking to improve brain and heart health through dietary changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIND Diet treatments for brain and heart health because they offer a unique approach compared to standard dietary recommendations. Unlike typical diets, which aren't personalized, one arm of this trial uses predictive analytics to tailor the MIND Diet to individuals who are most likely to benefit, potentially increasing its effectiveness. This diet emphasizes brain-boosting foods like leafy greens, nuts, and berries, which are not the usual focus of conventional diet plans. Additionally, the use of a meal delivery service like Daily Harvest® makes it convenient and easier for participants to adhere to the diet, addressing a common challenge in maintaining healthy eating habits.

What evidence suggests that this trial's treatments could be effective for brain and heart health?

Research shows that the MIND diet, which combines elements of the Mediterranean and DASH diets, is linked to improved brain and heart health. Studies have found that individuals following the MIND diet have a lower risk of dementia and experience slower declines in memory and thinking. The diet includes foods like leafy greens, nuts, berries, and whole grains, all known for their health benefits. Some research suggests that even moderate adherence to the MIND diet can help slow memory and thinking decline. This trial will compare two versions of the MIND diet: a standard MIND diet and a predictive analytics-informed MIND diet, both of which may enhance brain function and heart health. Additionally, a control group will follow a general diet based on the average American diet for comparison. ^{1 3 4 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. nutritionsource.hsph.harvard.edu nutritionsource.hsph.harvard.edu/healthy-weight/diet-reviews/mind-diet/

Diet Review: MIND Diet - The Nutrition Source Although the aim of the MIND diet is on brain health, it may also benefit heart health, diabetes, and certain cancers because it includes components of the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8042655/

Mediterranean-DASH Intervention for Neurodegenerative ... The MIND study is a randomized controlled intervention trial designed to compare the effects of the MIND diet with mild weight loss, versus participants' usual ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13521

Associations of the Mediterranean‐DASH Intervention for ... The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has been associated with lower risk of dementia and slower cognitive ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724003273

Mediterranean-Dash Intervention for Neurodegenerative ... Those with moderate adherence (tertile 2) to the MIND diet showed a non-significant trend toward slower rates of cognitive decline. In continuous models, the ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2804268

Association of the MIND Diet With the Risk of Dementia In aggregate, several constituents in the MIND diet have been suggested to be beneficial for cognitive health through the promotion of ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2302368

Trial of the MIND Diet for Prevention of Cognitive Decline in ... In a trial of the MIND diet that was designed to improve brain health, cognitive function and brain imaging outcomes at 3 years did not differ ...

7. massgeneral.org massgeneral.org/news/article/mind-diet-3-day-sample-meal-plan

MIND Diet 3-Day Sample Meal Plan The MIND diet highlights ten brain-supportive food groups, including leafy greens, berries, nuts, legumes, whole grains, fish, poultry, and ...