A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness
Inclusion Criteria:
- Aged 30 and older
- Premenopausal (may be confirmed by FSH)
- No previous diagnosis of cancer (except non-melanomatous skin cancer)
- Body mass index between 25-34 kg/m2
- Women must be expected to live in the Columbus area for the next 18 months.
- All women must present a letter of medical clearance from their primary care
physician.
Exclusion Criteria:
- Pregnant women or women who plan to become pregnant during the study period will not
be enrolled. Women who become pregnant during the intervention will be withdrawn from
the study.
- Women who are already participating in a formal weight loss program (such as Weight
Watchers)will not be eligible.
- Women with a medical history that precludes adherence to either of the two dietary
patterns will also be excluded. This includes a history of renal insufficiency,
gluten enteropathy, Crohn's disease or other medical conditions that significantly
impact nutritional status or metabolism. Women with either type I or controlled type
II diabetes will be eligible to participate in this trial.
- All medical problems must be managed and controlled. Lipid profile, blood glucose,
hemoglobin A1c, and blood pressure will be assessed at the screening visit. These
results will be reviewed by the study physician. Women who have abnormal values that,
at the discretion of the study physician, would benefit from medical management will
be referred to a primary care physician prior to considering them for enrollment.