Effect of a Low Glycemic Index Diet on Breast Density

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Low Glycemic Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Glycemic Diet<br> | Behavioral: Low Glycemic Diet<br>* Changing to low glycemic diet<br>|

What is the study measuring?
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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 |