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

Breast Cancer Clinical Trial

— LEAF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559194
• Other study ID #: LEAF
• Secondary ID: OSU 0372
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2012
• Last updated: April 10, 2014
• Start date: May 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2014
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

David P, Buckworth J, Pennell ML, Katz ML, DeGraffinreid CR, Paskett ED. A walking intervention for postmenopausal women using mobile phones and Interactive Voice Response. J Telemed Telecare. 2012 Jan;18(1):20-5. doi: 10.1258/jtt.2011.110311. Epub 2011 N — View Citation

Llanos AA, Krok JL, Peng J, Pennell ML, Vitolins MZ, Degraffinreid CR, Paskett ED. Effects of a walking intervention using mobile technology and interactive voice response on serum adipokines among postmenopausal women at increased breast cancer risk. Hor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women who lose weight when following 1 of 2 different calorie-restricted diets		18 months	No
Secondary	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	No

External Links

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