Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT06635005
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 45 years OR post-menopausal AND cis-gender women at study registration.
* Overweight or World Health Organization (WHO) class 1 obese as defined by a body mass index (BMI) of 25 to 35 kg/m\^2.
* High risk for breast cancer at the discretion of the physician, using standard definitions such as a Gail 5-year risk of ≥ 2% or Tyrer Cuzick version (v) 8.0 10-year risk of ≥ 5%.
* Concurrent or prior use of endocrine therapy is allowed. Any dose or schedule change is not permitted for the duration of the study.
* Currently established care or previously seen at the Ohio State University Comprehensive Cancer Center (OSUCCC) Stefanie Spielman Comprehensive Breast Center (SSCBC) high risk breast clinic.
Exclusion Criteria:
* Prior diagnosis of breast cancer within past 5 years.
* Metastatic breast cancer (at study start or during study period).
* BMI \> 35 kg/m\^2 or \< 25 kg/m\^2.
* Pre-menopausal women or \< 45 years of age.
* Assigned male at birth.
* Uncontrolled intercurrent illness including lung disease, heart disease, metabolic disease; exacerbations for disease in past 8 weeks; unstable on medications for chronic conditions in past 6 weeks. This could affect compliance and engagement with study intervention. Change in anti-hyperglycemic or lipid lowering medications is best avoided for the duration of the study unless deemed necessary by treating provider or required for acute exacerbation of existing illness.
* Type 1 diabetes mellitus (DM) or insulin dependent, or evidence of brittle diabetes.
* Presence of food allergies or intolerances to wheat, nuts, seeds, fish, or dairy foods.
* Currently on special diet for known metabolic or gastrointestinal disease, or planning to start a specific dietary regimen such as vegetarian, vegan, ketogenic, low-fat diets, etc.
* Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
* Unwilling or unable to follow protocol requirements.
* Pregnant, trying to get pregnant, or nursing.
* Any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study.
* Non-English speaking, as the teaching materials and educational sessions have not yet been translated into additional languages.
* Prisoners or other institutionalized patients.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT06635005
Study Brief:
Protocol Section:
NCT06635005