Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT05984888
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MIND Diet Intervention Group — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 26, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT) [ Time Frame: One day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Tonya S Orchard, PhD
[email protected]
614-292-7241
Kellie R Weinhold, MS
[email protected]
Tonya S Orchard, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

Related Studies