A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial.
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2019-09
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Abstract
Purpose
The objective of this study was to test a low-carbohydrate diet (LCD) plus walking to reduce androgen deprivation therapy (ADT)-induced metabolic disturbances.Materials and methods
This randomized multi-center trial of prostate cancer (PCa) patients initiating ADT was designed to compare an LCD (≤20g carbohydrate/day) plus walking (≥30 min for ≥5 days/week) intervention vs. control advised to maintain usual diet and exercise patterns. Primary outcome was change in insulin resistance by homeostatic model assessment at 6 months. To detect 20% reduction in insulin resistance, 100 men were required. The study was stopped early after randomizing 42 men due to slow accrual. Secondary outcomes included weight, body composition, lipids, and prostate-specific antigen (PSA). Changes from baseline were compared between arms using rank-sum tests.Results
At 6 months, LCD/walking reduced insulin resistance by 4% vs. 36% increase in control (p = 0.13). At 3 months, vs. control, LCD/walking arm significantly lost weight (7.8kg; p<0.001), improved insulin resistance (↑36%; p = 0.015), hemoglobin A1c (↓3.3%; p = 0.01), high-density lipoprotein (HDL) (↑13%; p = 0.004), and triglyceride (↓37%; p = 0.036). At 6 months, weight loss (10.6kg; p<0.001) and HDL (↑27%; p = 0.003) remained significant. LCD/walking preserved total body bone mineral count (p = 0.025), reduced fat mass (p = 0.002), lean mass (p = 0.036), and percent body fat (p = 0.004). There were no differences in PSA. Limitations include the effect of LCD, weight loss vs. walking instruction are indistinguishable, and small sample size.Conclusions
In an underpowered study, LCD/walking did not improve insulin sensitivity at 6 months. Given most secondary outcomes were improved at 3 months with some remaining improved at 6 months and a secondary analysis showed that LCD/walking reduced insulin resistance over the study, supporting future larger studies of LCD/walking intervention to reduce ADT-induced disturbances.Type
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Freedland, Stephen J, Lauren Howard, Jenifer Allen, Jordan Smith, Jennifer Stout, William Aronson, Brant A Inman, Andrew J Armstrong, et al. (2019). A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial. Prostate cancer and prostatic diseases, 22(3). pp. 428–437. 10.1038/s41391-019-0126-5 Retrieved from https://hdl.handle.net/10161/24273.
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Scholars@Duke
Lauren Howard
Lauren collaborates with different investigators in the Duke Cancer Institute on retrospective studies and clinical trials. She has experience with data management, data analysis, and preparation and editing of manuscripts. Some of her past projects have involved time-varying covariates, competing risks, and repeated measures. She is interested in methods for handling bias and confounding in observational research.
Eric Charles Westman
Dr. Westman is an Associate Professor of Medicine at Duke University. He is Board Certified in Obesity Medicine and Internal Medicine, and founded the Duke Keto Medicine Clinic with Dr. William S. Yancy Jr. in 2006 after 8 years of clinical research regarding low carbohydrate ketogenic diets.
He is Past-President and Master Fellow of the Obesity Medicine Association and Fellow of The Obesity Society. He is an editor of the textbook: Obesity: Evaluation & Treatment Essentials, and author of the New York Times Bestseller The New Atkins for a New You, Cholesterol Clarity, and Keto Clarity. He is co-founder of Adapt Your Life, an education and product company based on low carbohydrate concepts.
He is course coordinator for MED415c, a Fourth-Year Medical Student Elective on the Medical Management of Obesity, and a faculty member of the Duke Clinical Research Training Program.
Pao-Hwa Lin
My research interest lies generally in the area of dietary patterns and chronic diseases including hypertension using controlled feeding study and lifestyle intervention designs.
Two major controlled feeding clinical trials that I was involved in include the Dietary Approaches to Stop Hypertension (DASH) Study and the Dietary Approaches to Stop Hypertension-Sodium (DASH-Sodium) Study. In addition to being an active member for the diet committee for DASH, I also function as the chair of the diet committee for the DASH-Sodium study. I am familiar with the development and operation of a controlled feeding study, which means the process of study design, development of questionnaire/forms for data collection/monitoring, development of quality assurance procedure, and data analysis.
I've also helped with the design and implementation of the lifestyle behavioral intervention program for the Hypertension Improvement Project (HIP), PREMIER clinical trial, Weight Loss Maintenance trial (WLM), ENCORE study, and the Cell Phone Intervention for You (CITY) trial.
Key words: Diet, controlled feeding study, mineral, blood pressure, nutrition.
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