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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Conditions

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Breast Cancer Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Low Fat Diet + 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.

Group Type ACTIVE_COMPARATOR

Low Fat Diet plus exercise

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Low Carbohydrate diet + Exercise

Intervention Type BEHAVIORAL

Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet 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.

Interventions

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Low Fat Diet plus 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.

Intervention Type BEHAVIORAL

Low Carbohydrate diet + Exercise

Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Electra Paskett

Associate Director for Population Sciences, Comprehensive Cancer Center, Ohio State University; Marion N. Rowley Professor of Cancer Research and Director, Division of Cancer Prevention and Control

Responsibility Role PRINCIPAL_INVESTIGATOR