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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a specific healthy eating plan, the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay), can reduce "chemobrain" and other symptoms like fatigue and anxiety in women with stage II-III triple-negative breast cancer undergoing chemotherapy. Participants will be divided into two groups: one will follow the MIND diet, while the other will receive general health advice, with an opportunity to try the MIND diet later. This trial may suit women recently diagnosed with this type of breast cancer who are about to start or have recently started chemotherapy and can access the internet for virtual sessions. As an unphased trial, it offers a unique opportunity to explore the potential benefits of the MIND diet for improving quality of life during chemotherapy.

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.

Is there any evidence suggesting that the MIND eating plan is safe for women with breast cancer?

Research has shown that the MIND eating plan, which combines elements of the Mediterranean and DASH diets, is generally safe and easy to follow. This diet emphasizes nutritious, plant-based foods like leafy greens, nuts, and berries. Studies have found that people who adhere to this diet have a significantly lower risk of developing breast cancer.

The MIND diet has also been used in other studies to enhance brain health without causing major side effects. This suggests it could be a safe option for those looking to reduce memory and thinking problems related to cancer treatment. Although specific information on side effects from these studies is limited, the diet's focus on healthy foods supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIND Eating Plan for breast cancer because it takes a unique approach by focusing on dietary habits rather than traditional medical treatments like chemotherapy or hormone therapy. The MIND diet combines aspects of the Mediterranean and DASH diets, emphasizing foods that may support brain health and reduce inflammation, which could have potential benefits for cancer patients. Unlike conventional treatments, this plan offers a non-invasive option that integrates lifestyle changes, allowing patients to take an active role in their treatment and potentially improving overall well-being. Additionally, the use of wearable technology like Fitbits helps track physical activity, providing valuable data on how lifestyle modifications impact health outcomes.

What evidence suggests that the MIND eating plan might be an effective treatment for cancer-related cognitive impairment?

Research has shown that the MIND diet, which combines elements of the Mediterranean and DASH diets, may slow memory and thinking problems. Studies have found that people who follow the MIND diet tend to experience fewer memory and thinking issues as they age. Additionally, women who adhere to the MIND diet are less likely to develop breast cancer. This trial will compare two groups: one group will receive MIND diet counseling, focusing on nutritious, plant-based foods like leafy greens, nuts, and berries, which benefit brain health. The other group will receive general health recommendations. These findings suggest that the MIND diet may improve mental function and reduce "chemobrain" symptoms in women undergoing breast cancer treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Tonya Orchard, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07018986

The MIND-BC Study: MIND Diet for Breast Cancer Cognition a combination of the Mediterranean and DASH diets emphasizing consumption of high-nutrient, plant-based foods such as green leafy vegetables, nuts, berries, ...

2. 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 ...

3. 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 ...

4. 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 ...

5. 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 ...

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/PMC12313734/

The association of the MIND diet and its components with ... This was a cross-sectional study of 30 post-menopausal breast cancer survivors within one year of completing chemotherapy; 21 had complete data ...