Recruiting

MIND Diet

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT05984888

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

MIND Diet Intervention Group

General Health Curriculum (GHC) Group

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT05984888

Start date

Oct 26, 2023

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stage II-IV hormone receptor+, breast cancer diagnosis
  • Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy)
  • Within 4 weeks before or 12 weeks after starting initial systemic therapies (e.g. chemotherapy, targeted therapies such as CDK4/6 inhibitors, endocrine therapy)
  • Ability to access and use internet resources, including video calls using Zoom platform
  • English speaking

Exclusion Criteria:

  • History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
  • MIND diet score >8
  • Unwilling/unable to eat >2 types of MIND food
  • Receiving insulin therapy for diabetes
  • Diagnosis of triple negative breast cancer
  • Unable to give informed consent.

Study Design

Enrollment

43 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MIND-BC Intervention Group

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

active comparator: General Health Curriculum (GHC) Control

Sessions of non-diet related health topic education.

Interventions

MIND Diet Intervention Group

Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.

General Health Curriculum (GHC) Group

Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.

Primary outcome measure

  • Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT) [ Time Frame: One day ]
  • Remote assessment of cognition using the WAIS-IV Digit Span [ Time Frame: One day ]
  • Remote assessment of cognition using the Oral Trail Making Test [ Time Frame: One day ]
  • Remote assessment of cognition using the COWA Test [ Time Frame: One day ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Kellie R Weinhold, MS

weinhold.8@osu.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Tonya S Orchard, PhD

614-292-7241orchard.6@osu.edu

Kellie R Weinhold, MS

weinhold.8@osu.edu

Principal Investigator:

Tonya S Orchard, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Oct 3, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2025-10-03.