A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women

Completed · Not applicable

Conditions studied: Feasibility Pilot Study, Compliance

In brief

This clinical trial tests whether a new dietary pattern that consists of foods that lower the blood insulin response can reduce breast cancer risk in high-risk women. In a large group of patients, this new dietary pattern was associated with reduced risk of multiple cancers and reduced risk of long-term weight gain. Parts of this new dietary pattern are quite different from typical dietary recommendations, and much education is needed. Overall, compared to the typical American diet, this new dietary pattern is moderately low in total fat and saturated fat, low in protein from animal foods but high in protein from plant sources, high in fruits and vegetables, high in whole grains, and high in dietary fiber. We will determine if a low-insulinemic dietary pattern intervention is feasible and effective in reducing breast cancer risk in high-risk women.

Key facts

Study ID

NCT06635005

Run by

Ohio State University Comprehensive Cancer Center

People needed

34

Starts

2024-10-03

Expected to finish

2026-01-06

Last updated by the study team

2026-05-11

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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