NCT02744079

Comparison of Healthy Diets on Breast Cancer Markers

A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Low carbohydrate diet	45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal
BEHAVIORAL	Low fat diet	20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.

Timeline

• Start date: 2018-06-22
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2016-04-20
• Last updated: 2020-08-31

Locations

1 site across 1 country: United States