Recruiting

MIND Diet

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07018986

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MIND Diet

Usual Diet

Study Details

Brief summary:

This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We will recruit breast cancer survivors reporting CRCI with a MIND diet score < 8, based on a previously devised 14-item diet questionnaire designed to detect inadequate diet with respect to brain health (scores range from 0 to 14, with lower scores indicating a less adequate diet).14 Breast cancer survivors will have recently completed adjuvant treatment (i.e., 6 months to three years previously), to ensure that perceived cognitive impairment is likely chronic and due to cancer. To achieve maximal effect, the study consists of two 12-week phases 1) intervention phase, 2) maintenance phase.

Conditions

Breast Cancer

Study ID

NCT07018986

Start date

Jul 9, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Previously diagnosed with stage I-III breast cancer.
  • Able to speak and read English.
  • Able to consume foods orally.
  • >18 years of age.
  • Able to provide informed consent.
  • Have no documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., schizophrenia).
  • Report 'somewhat' to 'very much' cognitive impairment in the past week (i.e., a score ≥ 2 on a 0-4 scale) that they attribute to cancer or its treatment.
  • Report a MIND diet score < 10 (range 0 to 14, higher score equates to higher diet quality).
  • Willing to consume the MIND diet.
  • Completed adjuvant treatment 6 months to three years previously.

Exclusion Criteria:

  • Not meeting all of the inclusion criteria.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MIND Diet Arm

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The MIND diet arm will be asked to participate in weekly "check-in" sessions with a diet coach supervised by a registered dietitian. To evaluate the longer-term effects of the MIND diet as a part of lifestyle change, we will also conduct a 3-month follow-up assessment.

active comparator: Usual Diet Arm

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The usual diet participants will be provided with weekly grocery gift cards to purchase foods that follow their "usual" diet. Usual diet participants will also conduct a 3-month follow-up assessment.

Interventions

MIND Diet

a combination of the Mediterranean and DASH diets emphasizing consumption of high-nutrient, plant-based foods such as green leafy vegetables, nuts, berries, fish, and olive oil while limiting intake of foods high in saturated fat, pre-processed snacks, sugar, red and processed meat.

Usual Diet

Check-in sessions for the usual diet arm will focus on general health (e.g., healthy hair, skin, eyesight). None of the topics will include dietary information for the usual diet arm.

Primary outcome measure

  • Efficacy of the MIND diet: Self-reported cognition [ Time Frame: At 12 weeks and 3 months ]

Central Contacts and Locations

Central contacts

Crystal Bryant

813-745-2168Crystal.Bryant@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Sylvia Crowder, PhD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-02-05.