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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


Phase 3
30 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Weight Loss

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Trial Information

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 Women who become pregnant during the intervention will be withdrawn from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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of women who lose weight when following 1 of 2 different calorie-restricted diets

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Electra D. Paskett, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LEAF

NCT ID:

NCT01559194

Start Date:

May 2005

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Weight Loss
  • Breast Neoplasms
  • Weight Loss

Name

Location

Ohio State UniversityColumbus, Ohio  43210