PD14-12 SECONDARY OUTCOMES OF A PROSPECTIVE RANDOMIZED TRIAL OF DIETARY CARBOHYDRATE RESTRICTION FOR MEN INITIATING ANDROGEN DEPRIVATION THERAPY: CARBOHYDRATE AND PROSTATE STUDY I (CAPS1)

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II1 Apr 2018PD14-12 SECONDARY OUTCOMES OF A PROSPECTIVE RANDOMIZED TRIAL OF DIETARY CARBOHYDRATE RESTRICTION FOR MEN INITIATING ANDROGEN DEPRIVATION THERAPY: CARBOHYDRATE AND PROSTATE STUDY I (CAPS1) Stephen Freedland, William Aronson, Lauren Howard, Jordan Smith, Matthew Smith, Jennifer Stout, Jenifer Allen, Daniel George, Andrew Armstrong, Brant Inman, and Pao-Hwa Lin Stephen FreedlandStephen Freedland More articles by this author , William AronsonWilliam Aronson More articles by this author , Lauren HowardLauren Howard More articles by this author , Jordan SmithJordan Smith More articles by this author , Matthew SmithMatthew Smith More articles by this author , Jennifer StoutJennifer Stout More articles by this author , Jenifer AllenJenifer Allen More articles by this author , Daniel GeorgeDaniel George More articles by this author , Andrew ArmstrongAndrew Armstrong More articles by this author , Brant InmanBrant Inman More articles by this author , and Pao-Hwa LinPao-Hwa Lin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.798AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Metabolic side effects of androgen deprivation therapy (ADT) include diabetes, weight gain, increased fat mass, and osteoporosis. We previously showed in the CAPS1 trial that restricting carb intake in overweight men starting ADT led to weight and fat mass loss, suggestively improved insulin sensitivity, and reduced bone mass loss, thus reducing the risk of ADT-associated side effects vs. a control arm (no lifestyle changes). Here, we present secondary outcomes. We hypothesized a low-carb diet would favorably impact cholesterol, HbA1c, and HsCRP levels (a measure of systemic inflammation) without increasing adverse events (AEs). METHODS CAPS1 was a 6-month multi-center randomized phase II trial of dietary carb restriction + recommended exercise vs. no diet intervention control. Men had to have a BMI ≥24 kg/m2, be starting ADT for any reason except symptomatic metastases, and not be on meds that affect insulin. The low-carb arm was advised to eat <20 grams/carbs/day and increase moderate physical activity by 30 min/day for 5 days/wk. The control arm was told to make no lifestyle changes. Secondary outcomes included change in lipids, HsCRP, HbA1c between arms. Arms were compared using rank-sum. We also report adherence to the diet and AEs. RESULTS Of 42 randomized, 34 (20 control, 14 low-carb) completed the 6 month visit. At 6 months, a food recall survey showed no difference in calorie (p=0.88) or fat (p=0.19) intake between arms, however carb intake was lower (median 79 vs. 192 g, p=0.004) and protein intake was higher (median 116 vs. 74 g, p=0.021) in the low-carb arm. There was no difference in cholesterol, LDL, triglycerides, HbA1c, or HsCRP change from baseline to 6 months between arms (p≥0.09), however the low-carb diet let to a greater HDL increase (median 36% vs. 9%, p=0.003). In the low-carb arm, 22 AEs (17 mild, 5 moderate) were noted; 9 AEs were noted in the control arm (4 mild, 5 moderate). There were no severe AEs. CONCLUSIONS Among men starting ADT, despite non-ideal adherence, a low-carb diet with exercise was well tolerated with no difference in moderate AEs between arms. There were favorable changes in HDL and no negative effect on other lipids or inflammatory markers. These results, along with our primary results showing suggestively improved insulin sensitivity and significant weight loss (10.6 kg), provide further support for a low-carb diet plus exercise for men starting ADT. Further studies evaluating oncological safety and efficacy are ongoing. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e309 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Stephen Freedland More articles by this author William Aronson More articles by this author Lauren Howard More articles by this author Jordan Smith More articles by this author Matthew Smith More articles by this author Jennifer Stout More articles by this author Jenifer Allen More articles by this author Daniel George More articles by this author Andrew Armstrong More articles by this author Brant Inman More articles by this author Pao-Hwa Lin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...