Clinical trial · Interventional
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 )
NCT01237938CI-TRIAL-00014179terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): test
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Glycemic Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low Glycemic Diet
- interventionNames
- Behavioral: Low Glycemic Diet
Primary outcomes (1)
- measure
- Diet Change
- timeFrame
- 2 years
- 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)
Secondary outcomes (1)
- measure
- Biomarkers
- timeFrame
- 4, 8 & 12 months on Treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.