A Low-Insulinemic Dietary Intervention to Reduce Breast Cancer Risk in High-Risk Women
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. Evaluate the feasibility of translating the low-Empirical Dietary Index for Hyperinsulinemia (EDIH) dietary pattern intervention from epidemiologic cohorts to the clinic in a single arm phase I trial among postmenopausal women at high risk for cancer and evaluate safety. SECONDARY OBJECTIVES: I. Determine the change in patient reported outcomes (PRO) under the Low-EDIH dietary pattern at 12 weeks from baseline. II. Evaluate the change in cardiometabolic biomarker profiles at 12 weeks from baseline (a) glycemic control and insulin response parameters measured using fas…
Eligibility
- Age range
- 45+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 S…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherDietary Intervention
Receive the Low-EDIH dietary pattern intervention
- OtherMedical Device Usage and Evaluation
Wear an activity tracker
- BehavioralMotivational Interviewing
Undergo motivational interviews
- OtherNutritional Assessment
Participate in nutrition counseling
- OtherQuestionnaire Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio