Clinical trial NCT01559194: Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Weight Loss
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2012-03-21
Enrollment: 82
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 Women who become pregnant during the intervention will be withdrawn from the study.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

Primary outcomes:
measure: Number of women who lose weight when following 1 of 2 different calorie-restricted diets
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Electra D. Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Nov 3.
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. Horm Cancer. 2014 Apr;5(2):98-103. doi: 10.1007/s12672-013-0168-4. Epub 2014 Jan 17.
citation: Foraker RE, Pennell M, Sprangers P, Vitolins MZ, DeGraffinreid C, Paskett ED. Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial. J Womens Health (Larchmt). 2014 Aug;23(8):675-80. doi: 10.1089/jwh.2013.4638. Epub 2014 Jul 16.
citation: Llanos AA, Krok JL, Peng J, Pennell ML, Olivo-Marston S, Vitolins MZ, Degraffinreid CR, Paskett ED. Favorable effects of low-fat and low-carbohydrate dietary patterns on serum leptin, but not adiponectin, among overweight and obese premenopausal women: a randomized trial. Springerplus. 2014 Apr 4;3:175. doi: 10.1186/2193-1801-3-175. eCollection 2014.