Effect of a Low Glycemic Index Diet on Breast Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01237938
Recruitment Status : Terminated (test)
First Posted : November 10, 2010
Last Update Posted : April 3, 2014
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: Low Glycemic Diet Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (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 )
Study Start Date : March 2006
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low Glycemic Diet Behavioral: Low Glycemic Diet
Changing to low glycemic diet

Primary Outcome Measures :
  1. 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 :
  1. 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.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01237938     History of Changes
Other Study ID Numbers: I 71005
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014