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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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Date
2019-09
Authors
Freedland, Stephen J
Howard, Lauren
Allen, Jenifer
Smith, Jordan
Stout, Jennifer
Aronson, William
Inman, Brant A
Armstrong, Andrew J
George, Daniel
Westman, Eric
Lin, Pao-Hwa
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Abstract
<h4>Purpose</h4>The objective of this study was to test a low-carbohydrate diet (LCD) plus walking to reduce androgen deprivation therapy (ADT)-induced metabolic disturbances.<h4>Materials and methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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
Journal article
Subject
Humans
Prostatic Neoplasms
Body Weight
Weight Loss
Androgen Antagonists
Treatment Outcome
Walking
Body Composition
Aged
Middle Aged
Male
Diet, Carbohydrate-Restricted
Healthy Lifestyle
Metabolic Syndrome
Permalink
https://hdl.handle.net/10161/24273
Published Version (Please cite this version)
10.1038/s41391-019-0126-5
Publication Info
Freedland, Stephen J; Howard, Lauren; Allen, Jenifer; Smith, Jordan; Stout, Jennifer; Aronson, William; ... Lin, Pao-Hwa (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.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Armstrong

Andrew John Armstrong

Professor of Medicine
1. Predictors of sensitivity and clinical efficacy of therapies in advanced prostate cancer 2. Novel designs of clinical trials and pharmacodynamic/translational studies in prostate, kidney, bladder cancer 3. Pre-operative models for drug development of novel agents in human testing in prostate cancer 4. Novel therapies and drug development for prostate, renal, bladder, and testicular cancer 5. Design of rational combination therapies in men with metastatic hormone-refra
George

Daniel James George

Professor of Medicine
Howard

Lauren Howard

Biostatistician III
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.
Inman

Brant Allen Inman

Professor of Surgery
Clinical research interests: Clinical trials of novel diagnostic tests and therapies for genitourinary malignancies, with a strong focus on bladder cancer. Basic science research interests: Immune therapies for cancer, hyperthermia and heat-based treatment of cancer, molecular biology of genitourinary cancers, novel diagnostics and therapies for genitourinary cancers
Lin

Pao-Hwa Lin

Associate Professor in Medicine
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
Westman

Eric Charles Westman

Associate Professor of Medicine
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 & Treatme
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