Comparison of Healthy Diets on Breast Cancer Markers (KetoBreast)

Albert Einstein College of Medicine

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Low fat diet; Behavioral: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02744079

2016-6346

Details and patient eligibility

About

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

Full description

A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Enrollment: 11 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Women with biopsy proven breast cancer.

Exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Low carbohydrate diet

Active Comparator group

Description:

45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal

Treatment:

Behavioral: Low carbohydrate diet

Low fat diet

Active Comparator group

Description:

20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal

Treatment:

Behavioral: Low fat diet