This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)
standard of care aromatase inhibitors
Cedars-Sinai Medical Center
Los Angeles, California, United States
Diet adherence
Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if \<20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient \<20% of calories were obtained from carbohydrates).
Time frame: 6 months
Change in tumor size
Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group.
Time frame: 6 months
Mean change in Ki67
Change in Ki67 between pre-and post- intervention
Time frame: 6 months
Mean change in weight
Change in weight between pre- and post- intervention
Time frame: 6 months
Mean change in HbA1c
Change in HbA1c between pre- and post- intervention
Time frame: 6 months
Mean change in insulin
Change in insulin between pre- and post- intervention
Time frame: 6 months
Mean change in triglycerides
Change in triglycerides between pre- and post- intervention
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean change in LDL cholesterol
Change in LDL cholesterol between pre- and post- intervention
Time frame: 6 months
Mean change in HDL cholesterol
Change in HDL cholesterol between pre- and post- intervention
Time frame: 6 months
Mean change in total cholesterol
Change in total cholesterol between pre- and post- intervention
Time frame: 6 months