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.
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 articleSubject
HumansProstatic Neoplasms
Body Weight
Weight Loss
Androgen Antagonists
Treatment Outcome
Walking
Body Composition
Aged
Middle Aged
Male
Diet, Carbohydrate-Restricted
Healthy Lifestyle
Metabolic Syndrome
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https://hdl.handle.net/10161/24273Published Version (Please cite this version)
10.1038/s41391-019-0126-5Publication 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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Show full item recordScholars@Duke
Andrew John Armstrong
Professor of Medicine
I am a clinical and translational investigator focused on precision therapies and
biomarkers in advanced prostate and other GU cancers. I oversee a large research
team of clinical and lab based investigators focused on improving patient outcomes,
preventing metastatic disease, and understanding the biology of aggressive prostate
cancer. Some key themes:1. Predictors of sensitivity and clinical efficacy of therapies
in advanced prostate cancer 2. Novel designs of clinical
Daniel James George
Eleanor Easley Distinguished Professor in the School of Medicine
Lauren Howard
Biostatistician, Senior
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.
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
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 chair
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
Alphabetical list of authors with Scholars@Duke profiles.

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