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.

dc.contributor.author

Freedland, Stephen J

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Howard, Lauren

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Allen, Jenifer

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Smith, Jordan

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Stout, Jennifer

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Aronson, William

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Inman, Brant A

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Armstrong, Andrew J

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George, Daniel

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Westman, Eric

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Lin, Pao-Hwa

dc.date.accessioned

2022-02-01T01:32:42Z

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2022-02-01T01:32:42Z

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2019-09

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2022-02-01T01:32:42Z

dc.description.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.
dc.identifier

10.1038/s41391-019-0126-5

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1365-7852

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1476-5608

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https://hdl.handle.net/10161/24273

dc.language

eng

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Springer Science and Business Media LLC

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Prostate cancer and prostatic diseases

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10.1038/s41391-019-0126-5

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Humans

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Prostatic Neoplasms

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Body Weight

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Weight Loss

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Androgen Antagonists

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Treatment Outcome

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Walking

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Body Composition

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Aged

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Middle Aged

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Male

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Diet, Carbohydrate-Restricted

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Healthy Lifestyle

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Metabolic Syndrome

dc.title

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.

dc.type

Journal article

duke.contributor.orcid

Howard, Lauren|0000-0003-3355-4483

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Inman, Brant A|0000-0002-6060-4485

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Armstrong, Andrew J|0000-0001-7012-1754

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Lin, Pao-Hwa|0000-0001-5982-9241

pubs.begin-page

428

pubs.end-page

437

pubs.issue

3

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Duke

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School of Medicine

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Staff

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Pharmacology & Cancer Biology

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Medicine

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Surgery

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Medicine, General Internal Medicine

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Medicine, Medical Oncology

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Medicine, Nephrology

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Surgery, Urology

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Duke Cancer Institute

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Duke Molecular Physiology Institute

pubs.publication-status

Published

pubs.volume

22

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