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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer treatments are an important contributor to dramatic improvements in the long-term survival of women with BC. However, cancer treatment can lead to cognitive impairment and declines in quality of life in women with BC. Many cancer survivors experience memory and brain function decline following chemotherapy which can last for years. A newer diet pattern, Mediterranean-DASH \[Dietary Approaches to Stop Hypertension\] Intervention for Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which may help alleviate negative cognitive outcomes from cancer treatments. This randomized controlled trial aims to investigate the effect of the MIND diet on cognitive functions in women with invasive BC starting systemic therapies.

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 data supports the effectiveness of the MIND Diet Intervention for Breast Cancer treatment?

The MIND diet, which combines elements of the Mediterranean and DASH diets, has shown potential benefits in reducing cognitive decline and may have neuroprotective effects. While there is no direct evidence for breast cancer, its components have been associated with overall health benefits and reduced mortality in older adults. ^{1 2 3 4 5}

Is the MIND diet safe for humans?

The MIND diet has been studied for its effects on brain health and cognitive performance, and no safety concerns have been reported in these studies, suggesting it is generally safe for humans. ^{2 3 5 6 7}

How is the MIND Diet Intervention treatment for breast cancer different from other treatments?

The MIND Diet Intervention is unique because it focuses on dietary changes, combining elements of the Mediterranean and DASH diets, which are known for their heart and brain health benefits, rather than using medication or surgery. This approach is novel for breast cancer as it emphasizes nutrition to potentially reduce cancer risk, unlike traditional treatments that often involve drugs or invasive procedures. ^{1 2 3 4 8}

Research Team

Tonya S Orchard, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 2,598 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 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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Adherence to the MIND Diet and Risk of Breast Cancer: A Case-control Study. [2021]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: a randomized controlled trial. [2022]

8. India pubmed.ncbi.nlm.nih.gov

The association between adherence to MIND diet and risk of breast cancer: A case-control study. [2021]