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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
6
Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)
standard of care aromatase inhibitors
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mean change in weight
Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group
Time frame: 6 months
Changes in serum estradiol
Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in fasting glucose
Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in insulin
Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in HbA1c
Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in triglycerides
Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in LDL
Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in HDL
Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
Changes in cholesterol
Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group
Time frame: 6 months
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