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

Phase 3

Completed

• Conditions: Weight Loss; Breast Cancer
• Interventions: Behavioral: Low Carbohydrate diet + Exercise; Behavioral: Low Fat Diet plus exercise

• Registration Number: NCT01559194
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-21
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet + Exercise	Low Carbohydrate diet + Exercise	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.
Low Fat Diet + Exercise	Low Fat Diet plus exercise	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.

Primary Outcome Measures

Name	Time	Method
Number of women who lose weight when following 1 of 2 different calorie-restricted diets	18 months

Secondary Outcome Measures

Name	Time	Method
Number of women that long-term weight loss impacted biomarkers (including Insulin-like growth factor (IGF)- 1 and IGFBP-3) associated with breast cancer risk	12 months

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States