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.
Study Goal
The researchers aimed to determine the effects of two different weight loss dietary patterns (high carbohydrate, low fat vs. low carbohydrate, high fat) on biomarkers related to tumorigenesis and long-term survival in overweight or obese postmenopausal breast cancer survivors.
Results Summary
The study protocol outlines a comparison of dietary patterns but does not report results; it focuses on measuring biomarkers such as high sensitivity C-reactive protein, inflammation markers, and sex hormone metabolism to assess the impact of weight loss magnitude and dietary composition.
Population
Overweight or obese postmenopausal breast cancer survivors (BMI: 25.0 to 34.9 kg/m²).
Effective Dosage
Not specified (dietary counseling and clinical visits described).
Duration
6 months (with multiple visits).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
weight loss | increase | long term survival | overweight or obese breast cancer patients | - | associated with an improved prognosis | #1 |
weight loss dietary patterns that vary markedly in fat and carbohydrate contents | neutral | biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival | overweight or obese postmenopausal breast cancer survivors | - | effects | #2 |
weight loss | increase | biomarkers | overweight or obese postmenopausal breast cancer survivors | - | determine how much weight must be lost for biomarkers to change | #3 |
high carbohydrate, low fat diet versus a low carbohydrate, high fat diet | neutral | biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism | overweight or obese postmenopausal breast cancer survivors | - | effects | #4 |
excess weight for height | decrease | long term survival | breast cancer patients | - | associated with poor prognosis | #5 |
dietary pattern and magnitude of weight loss | neutral | long term survival | breast cancer patients | - | effects | #6 |
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/DESIGN: 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. DISCUSSION: 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. CLINICAL TRIAL REGISTRATION: CA125243.