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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

Prostate Cancer and Prostatic Diseases (2019) | Download Citation

Subjects

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.

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Acknowledgements

This study was funded by the Atkins Foundation, AUA, NIH K24 CA160653.

Author information

Affiliations

  1. Center for Integrated Research on Cancer and Lifestyle, Samuel Oschin Comprehensive Cancer Institute and Department of Surgery, Division of Urology Cedars-Sinai Medical Center, Section of Urology, Los Angeles, CA, USA

    • Stephen J. Freedland
  2. Department of Surgery, Durham Veterans Affairs Medical Center, Durham, NC, USA

    • Stephen J. Freedland
  3. Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA

    • Lauren Howard
  4. Translational Population Health Research, Duke Clinical and Translational Science Institute, Kannapolis, NC, USA

    • Jenifer Allen
  5. Department of Medicine, Nephrology Division, Sarah W. Stedman Nutrition and Metabolism Center, Duke University Medical Center, Durham, NC, USA

    • Jordan Smith
    •  & Pao-Hwa Lin
  6. Division of Urology, Duke University Medical Center, Durham, NC, USA

    • Jennifer Stout
    • , Brant A. Inman
    •  & Daniel George
  7. Urology Section, Department of Surgery, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA

    • William Aronson
  8. Department of Urology, UCLA School of Medicine, Los Angeles, CA, USA

    • William Aronson
  9. Department of Medicine, Division of Urology, Duke University Medical Center, Durham, NC, USA

    • Andrew J. Armstrong
  10. Department of Medicine, Duke University Medical Center, Durham, NC, USA

    • Eric Westman

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Conflict of interest

The authors declare that they have no conflict of interest.

Corresponding author

Correspondence to Stephen J. Freedland.

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DOI

https://doi.org/10.1038/s41391-019-0126-5