MIND Diet Intervention for Breast Cancer

(MIND-BC Trial)

Recruiting at 1 trial location

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Insulin

Disqualifiers: Dementia, Stroke, Brain injury, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-12 weeks

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the MIND diet can improve brain function in women with breast cancer who are beginning treatments like chemotherapy. The MIND diet, rich in brain-protective nutrients, limits foods detrimental to brain health. Participants will either follow the MIND diet with a nutritionist's guidance or receive general health tips unrelated to diet. Women diagnosed with stage II-IV hormone receptor-positive breast cancer, who are post-menopausal and about to start or have just started systemic cancer treatments, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore the MIND diet's potential brain health benefits during cancer treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should be within four weeks of starting systemic therapies, which suggests you may continue with those treatments.

What prior data suggests that the MIND diet is safe for women with breast cancer?

Research shows that the MIND diet is generally safe and easy for most people to follow. This diet emphasizes foods rich in nutrients that reduce inflammation, like omega-3 fatty acids and B-vitamins, while avoiding foods harmful to the brain, such as red meat and sweets.

Studies have found that the MIND diet supports brain health and may lower the risk of developing breast cancer. These studies reported no major negative side effects. Designed to aid brain function, the diet addresses a common concern for breast cancer patients undergoing treatment.

Overall, the MIND diet appears to be a safe choice for those seeking to maintain or improve brain health during and after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIND Diet Intervention for breast cancer because it offers a unique, nutrition-focused approach that isn't widely used in current cancer treatments. Unlike typical treatments like surgery, chemotherapy, or radiation, the MIND Diet emphasizes personalized nutrition counseling to potentially impact health outcomes. This intervention is distinctive because it involves individualized, behaviorally based nutrition guidance provided by professional dietitians, which could help improve patients' overall well-being and quality of life. By focusing on diet, this intervention may offer a non-invasive complement to traditional cancer therapies, potentially reducing side effects and enhancing recovery.

What evidence suggests that the MIND diet is effective for cognitive function in breast cancer patients?

Research suggests that the MIND diet, which participants in this trial may receive, can help protect brain functions and slow memory and thinking problems. One study found that women who followed the MIND diet experienced a slower rate of memory decline. The diet includes nutrients like omega-3 fatty acids and B-vitamins, which benefit brain health. Another study found that women who closely followed the MIND diet had a 60% lower chance of developing breast cancer compared to those who did not. While more research is needed to confirm these findings, the MIND diet shows promise for supporting brain health in breast cancer patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Tonya S Orchard, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for English-speaking, post-menopausal women with Stage II-IV hormone receptor-positive breast cancer. They must be about to start systemic therapies like chemotherapy within +/- 4 weeks and cannot have a history of cognitive impairments or conditions such as dementia or stroke. Women already following the MIND diet closely or those unable to consume its foods are excluded.

Inclusion Criteria

My breast cancer is hormone receptor positive and is stage II-IV.

I am post-menopausal.

English speaking

Exclusion Criteria

I am on insulin therapy for my diabetes.

My breast cancer is triple negative.

I am unable to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic cancer therapies and follow a MIND diet intervention to assess cognitive functions

6-12 weeks

Weekly visits (virtual and in-person)

Follow-up

Participants are monitored for cognitive function and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• General Health Curriculum (GHC) Group
• MIND Diet Intervention

Trial Overview The study tests if the MIND Diet, rich in anti-inflammatory nutrients and low in unhealthy foods, can protect brain function during cancer treatment. Participants will either follow this special diet or receive general health education (GHC), randomly assigned to see which method better supports cognitive functions.

How Is the Trial Designed?

Group I: MIND-BC Intervention Group Experimental Treatment 1 Intervention

Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.

Group II: General Health Curriculum (GHC) Control Active Control 1 Intervention

Sessions of non-diet related health topic education.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

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 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]

In a study of 350 women with breast cancer and 700 healthy controls, those who adhered closely to the MIND diet had a 60% lower risk of developing breast cancer compared to those with the lowest adherence.

Postmenopausal women and normal-weight women who followed the MIND diet also showed significantly reduced odds of breast cancer, suggesting that this dietary pattern may be protective against the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the MIND Diet and Risk of Breast Cancer: A Case-control Study. Aghamohammadi, V., Salari-Moghaddam, A., Benisi-Kohansal, S., et al.[2021]

In a study of 339 individuals with obesity, those who adhered more closely to the MIND diet showed lower levels of stress and higher insulin sensitivity, suggesting potential mental health and metabolic benefits.

The highest MIND diet scores were linked to increased intake of brain-healthy foods and a significant reduction in the consumption of unhealthy sweets and pastries, indicating a positive dietary shift.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. Ardekani, AM., Vahdat, S., Hojati, A., 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 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]

The MIND diet, combined with calorie restriction, significantly improved cognitive performance in areas such as working memory, verbal recognition memory, and attention in a study of 37 obese women over 3 months.

MRI results indicated that the MIND diet led to structural brain changes, including an increase in the surface area of the inferior frontal gyrus, suggesting it may help reverse cognitive decline associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: a randomized controlled trial. Arjmand, G., Abbas-Zadeh, M., Eftekhari, MH.[2022]

In a case-control study involving 150 breast cancer patients and 150 matched controls, adherence to the MIND diet showed no significant association with the risk of breast cancer among Iranian women.

The study found consistent results for both pre-menopausal and post-menopausal women, indicating that following the MIND diet did not affect breast cancer odds, suggesting the need for further research to explore these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between adherence to MIND diet and risk of breast cancer: A case-control study. Sheikhhossein, F., Imani, H., Amini, MR., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9615230/

a case-control study among iranian adult women - PMC Our findings revealed that higher adherence to the MIND diet was associated with decreased BC risk, which was strongly observed among women with a history of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820920302536

Adherence to the MIND Diet and Risk of Breast Cancer After adjustment for age and energy intake, women in the top tertile of the MIND diet score had 60% lower odds of breast cancer than women in the bottom tertile ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-05451

MIND Dietary Intervention to Prevent Cognitive Changes in ... Data has shown that following the MIND diet pattern may slow the rate of cognitive decline. The MIND diet intervention may prevent cognitive changes in women ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36303232/

a case-control study among iranian adult women Our findings revealed that higher adherence to the MIND diet was associated with decreased BC risk, which was strongly observed among women ...

5. mdpi.com mdpi.com/2072-6643/17/16/2687

Associations of the MIND Diet with Human Health Outcomes The MIND diet was designed as an intervention to delay neurodegeneration and has been explored by systematic reviews for associations with cognition and, ...

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

Mediterranean-DASH Intervention for Neurodegenerative ... We hypothesize that the MIND diet will reduce the rate of cognitive decline and total brain volume loss compared with a usual diet. MATERIALS AND METHODS.

8. d-nb.info d-nb.info/1278010157/34

The relationship between Mediterranean- DASH diet ... Recently, a new index called Mediterranean-DASH diet intervention for the neurodegenerative delay (MIND) diet has been developed using the related components of ...