Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk (LEAF)
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|ClinicalTrials.gov Identifier: NCT01559194|
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : April 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Weight Loss||Behavioral: Low Fat Diet plus exercise Behavioral: Low Carbohydrate diet + Exercise||Phase 3|
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.
- 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
- 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 Women who become pregnant during the intervention will be withdrawn from the study.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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
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.
- Number of women who lose weight when following 1 of 2 different calorie-restricted diets [ Time Frame: 18 months ]
- 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 ]
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
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43201|
|Principal Investigator:||Electra D. Paskett, PhD||The Ohio State University Comprehensive Cancer Center|