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

40 Years
60 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

- Have a study baseline mammographic density of at least 50% as estimated by

- 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

- Successful completion of three baseline telephone-administered 24- hour dietary

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Diet Change

Outcome Description:

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)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Susan McCann, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 71005



Start Date:

March 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263