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Effect of a Low Glycemic Index Diet on Breast Density

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01237938
Enrollment
46
Registered
2010-11-10
Start date
2006-03-31
Completion date
Unknown
Last updated
2014-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

Changing to low glycemic diet

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Diet Change2 yearsTo 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

MeasureTime frameDescription
Biomarkers4, 8 & 12 months on TreatmentTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026