Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk (LEAF)

The Ohio State University

Status and phase: Completed; Phase 3

Conditions: Weight Loss; Breast Cancer

Treatments: Behavioral: Low Fat Diet plus exercise; Behavioral: Low Carbohydrate diet + Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01559194

OSU 0372 (Other Identifier)

LEAF

Details and patient eligibility

About

The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.

Full description

We examined a low carbohydrate diet (40% carbohydrates, 30% protein, 30% fat) versus a low fat diet (60% carbohydrates, 20% protein, 20% fat) to determine the impact of these dietary patterns, combined with exercise, on weight loss, body shape and body composition.

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Enrollment: 82 patients

Sex: Female

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

82 participants in 2 patient groups

Low Fat Diet + Exercise

Active Comparator group

Description:

Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Treatment:

Behavioral: Low Fat Diet plus exercise

Low Carbohydrate Diet + Exercise

Active Comparator group

Description:

Subjects were educated about a low carbohydrate diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.

Treatment:

Behavioral: Low Carbohydrate diet + Exercise