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

This study has been completed.
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01559194
First received: March 19, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Breast Cancer
Weight Loss
Behavioral: Low Fat Diet plus exercise
Behavioral: Low Carbohydrate diet + Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of women who lose weight when following 1 of 2 different calorie-restricted diets [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: March 19, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014