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Effect of a Low Glycemic Index Diet on Breast Density

This study has been terminated.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: November 8, 2010
Last updated: April 2, 2014
Last verified: April 2014
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.

Condition Intervention
Breast Cancer Behavioral: Low Glycemic Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Diet Change [ Time Frame: 2 years ]
    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)

Secondary Outcome Measures:
  • Biomarkers [ Time Frame: 4, 8 & 12 months on Treatment ]
    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.

Enrollment: 46
Study Start Date: March 2006
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Glycemic Diet Behavioral: Low Glycemic Diet
Changing to low glycemic diet


Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01237938

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Susan McCann, PhD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01237938     History of Changes
Other Study ID Numbers: I 71005
Study First Received: November 8, 2010
Last Updated: April 2, 2014 processed this record on July 19, 2017