Effect of a Low Glycemic Index Diet on Breast Density

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01237938
• Other study ID #: I 71005
• Status: Terminated
• Phase: N/A
• First received: November 8, 2010
• Last updated: April 2, 2014
• Start date: March 2006

Study information

• Verified date: April 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Low Glycemic Diet
Changing to low glycemic diet

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No