Effect of a Low Glycemic Index Diet on Breast Density

Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )

This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Low Glycemic Diet

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Are between 40 and 60 years of age
• Still menstruating with at least 10 menstrual cycles in the previous 12 months
• Not Taking hormone replacement therapy
• Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
• Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
• No history of breast augmentation or reduction surgery
• Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
• Have no history of diabetes or other metabolic diseases requiring dietary modification
• Have a study baseline mammographic density of at least 50% as estimated by mammographer
• BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
• Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
• Successful completion of three baseline telephone-administered 24- hour dietary recalls

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Glycemic Diet	Behavioral: Low Glycemic Diet; Changing to low glycemic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet Change	To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (> 50% of breast area occupied by radiological density)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers	To estimate the effect of a low glycemic index diet on breast cancer related biomarkers, including those associated with carbohydrate, growth and steroid hormaone metabolism and mammograhic density. Result from this aim will provide important preliminary data for use in planning a larger clinical trial.	4, 8 & 12 months on Treatment

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Susan McCann, PhD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Estimate): April 3, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: I 71005