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Brief Title: BREADS: Breast Adjuvant Diet Study
Official Title: IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study
Study ID: NCT04189263
Brief Summary: This is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months. Anthropomorphic measurements (such as heart rate, weight, and body measurement) and questionnaires will be taken at all three visits. After screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (Arm A) or to a control group (Arm B). Patients randomized to Arm A will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cedars-Sinai Medical Center, Los Angeles, California, United States
Name: Farin Amersi, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR