title: Effect of a low fat versus a low carbohydrate weight loss dietary intervention on biomarkers of long term survival in breast cancer patients ('CHOICE'): study protocol.
abstract: BACKGROUND
  Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. However, it is not clear whether the macronutrient composition of the chosen weight loss dietary plan imparts further prognostic benefit. A study protocol is presented for a dietary intervention to investigate the effects of weight loss dietary patterns that vary markedly in fat and carbohydrate contents on biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival. The study will also determine how much weight must be lost for biomarkers to change in a favorable direction.
  
  
  METHODS
  Approximately 370 overweight or obese postmenopausal breast cancer survivors (body mass index: 25.0 to 34.9 kg/m²) will be accrued and assigned to one of two weight loss intervention programs or a non-intervention control group. The dietary intervention is implemented in a free living population to test the two extremes of popular weight loss dietary patterns: a high carbohydrate, low fat diet versus a low carbohydrate, high fat diet. The effects of these dietary patterns on biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism will be measured. Participants will attend 3 screening and dietary education visits, and 7 monthly one-on-one dietary counseling and clinical data measurement visits in addition to 5 group visits in the intervention arms. Participants in the control arm will attend two clinical data measurement visits at baseline and 6 months. The primary outcome is high sensitivity C-reactive protein. Secondary outcomes include interleukin-6, tumor necrosis factor-α, insulin-like growth factor-1 (IGF), IGF binding protein-3, 8-isoprostane-F2-alpha, estrone, estradiol, progesterone, sex hormone binding globulin, adiponectin, and leptin.
  
  
  CONCLUSIONS
  While clinical data indicate that excess weight for height is associated with poor prognosis for long term survival, little attention is paid to weight control in the clinical management of breast cancer. This study will provide information that can be used to answer important patient questions about the effects of dietary pattern and magnitude of weight loss on long term survival following breast cancer treatment.
  
  
  BACKGROUND
  CA125243.
authors: Cancer Prevention Laboratory, Colorado State University, Fort Collins, CO, USA.
authors: Scot M
authors: SM
authors: Sedlacek
authors: Mary C
authors: MC
authors: Playdon
authors: Pamela
authors: P
authors: Wolfe
authors: John N
authors: JN
authors: McGinley
authors: Mark R
authors: MR
authors: Wisthoff
authors: Elizabeth A
authors: EA
authors: Daeninck
authors: Weiqin
authors: W
authors: Jiang
authors: Zongjian
authors: Z
authors: Zhu
authors: Henry J
authors: HJ
authors: Thompson
mesh_terms: D052242:Adiponectin / Q000097:blood; D000273:Adipose Tissue / Q000378:metabolism; D000465:Algorithms; D000704:Analysis of Variance; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000178:diet therapy* / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D004038:Diet, Reducing; D004040:Dietary Carbohydrates / Q000008:administration & dosage*; D004041:Dietary Fats / Q000008:administration & dosage*; D004967:Estrogens / Q000097:blood; D005260:Female; D005947:Glucose / Q000378:metabolism; D006706:Homeostasis / Q000187:drug effects; D006801:Humans; D015850:Interleukin-6 / Q000378:metabolism; D020738:Leptin / Q000097:blood; D008875:Middle Aged; D009765:Obesity / Q000097:blood; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D017698:Postmenopause / Q000097:blood; D017382:Reactive Oxygen Species / Q000378:metabolism; D017741:Survivors; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism; D061217:Weight Reduction Programs / Q000379:methods / Q000706:statistics & numerical data
chemical_list: D052242:Adiponectin; D014408:Biomarkers, Tumor; D004040:Dietary Carbohydrates; D004041:Dietary Fats; D004967:Estrogens; D015850:Interleukin-6; D020738:Leptin; D017382:Reactive Oxygen Species; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D005947:Glucose