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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01559194
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Weight Loss Behavioral: Low Fat Diet plus exercise Behavioral: Low Carbohydrate diet + Exercise Phase 3

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2005
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.
Active Comparator: 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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Number of women who lose weight when following 1 of 2 different calorie-restricted diets [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559194


Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43201
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Breast Cancer Research Foundation
Investigators
Principal Investigator: Electra D. Paskett, PhD The Ohio State University Comprehensive Cancer Center
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01559194     History of Changes
Other Study ID Numbers: LEAF
OSU 0372 ( Other Identifier: Ohio State University )
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Breast Neoplasms
Body Weight
Weight Loss
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Body Weight Changes