MIND Diet for Breast Cancer

(MIND-TNBC 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

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: 8

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on diet and does not mention medication changes.

What data supports the effectiveness of the MIND Diet treatment for breast cancer?

Research suggests that the MIND diet, which combines elements of the Mediterranean and DASH diets, may help improve brain health and reduce the risk of neurological diseases. While direct evidence for breast cancer is limited, the diet's overall health benefits could potentially support cancer prevention. ^{1 2 3 4 5}

Is the MIND Diet safe for humans?

The MIND Diet, which combines elements of the Mediterranean and DASH diets, has been studied for its effects on brain health and other conditions. Research involving different groups, including those with obesity, has not reported any major safety concerns, suggesting it is generally safe for humans. ^{1 2 5 6 7}

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

The MIND Diet is unique because it combines elements of the Mediterranean and DASH diets, focusing on foods that may reduce the risk of neurodegenerative diseases, and is being explored for its potential to lower breast cancer risk, unlike traditional treatments that typically involve medication or surgery. ^{1 2 3 4 6}

What is the purpose of this trial?

The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression. Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions. Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely. Participants will: * Be randomized to MIND or GHC interventions * Complete all study measures remotely (by online questionnaires, virtual visits and mail ) * Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks * Be sent some of the key foods in the MIND eating plan during the MIND intervention * Be contacted for follow-up measures 6 months after interventions

Research Team

Tonya Orchard, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for women aged 40-65 with newly diagnosed stage II-III triple negative breast cancer, who are about to start or have started chemotherapy within the last 6 months. Participants must be able to use internet resources and video calls for remote sessions.

Inclusion Criteria

I am between 40 and 65 years old.

Ability to access and use internet resources, including video calls using Zoom platform

English speaking

Exclusion Criteria

Current healthy eating pattern reflected by high MIND diet score (e.g. > 8)

Unwilling/unable to eat > 2 types of MIND food (e.g. avoids > 2 categories or food groups such as leafy greens, olive oil and non-fried fish)

Currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MIND diet counseling or general health recommendations over 12 weeks, with virtual sessions and dietary interventions.

12 weeks

8 virtual sessions

Follow-up

Participants are monitored for sustainability of dietary changes and outcome measures 6 months post-intervention.

6 months

Open-label extension (optional)

Participants initially in the general health recommendations group may opt into the MIND diet intervention after the 6-month follow-up.

Treatment Details

Interventions

• MIND Eating Plan

Trial Overview The study tests if the MIND eating plan can reduce 'chemobrain' and other symptoms like fatigue, sleep issues, anxiety, and depression during chemotherapy. It compares this diet with general health coaching over a period of 12 weeks with follow-up after six months.

Participant Groups

Group I: Arm I (MIND-TNBC counseling) Experimental Treatment 5 Interventions

Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.

Group II: Arm II (general health recommendations counseling) Active Control 5 Interventions

Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Findings from Research

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 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]

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]

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 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]

References

1. 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]

2. India pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

5. 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]

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

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

7. 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]