Whole-food plant-based diet (WFPBD) to control weight and metabo-inflammation in overweight/obese men with prostate cancer (PC) receiving androgen deprivation therapy (ADT): A multi-center randomized control trial.

• DOI: 10.1200/jco.2023.41.16_suppl.tps5098
• Publication Date: 2023-06-04T15:49:12Z
• Authors: Nicole Jacobs; Katie Hootman; Victoria Fischer; Nadja Pinnavaia; Karen Sfanos; Jones T. Nauseef; Ana M. Molina; Cora N. Sternberg; Scott T. Tagawa; Karla V. Ballman; Mark N. Stein; Channing Judith P...; David M. Nanus
• Keywords: 2. Zero hunger; 03 medical and health sciences; 0302 clinical medicine; 3. Good health

TPS5098 Background: Obesity promotes a chronic inflammatory state that is associated with PC progression. ADT can cause significant side effects including weight gain, accumulation of body fat, insulin resistance, and an increased risk diabetes cardiovascular disease. A WFPBD has been shown to promote loss, decrease inflammation, shift gut microbial profiles microbiome sensitivity. We hypothesize behavior intervention will loss reduction in adiposity overweight/obese patients on biomarkers metabo-inflammation; WFPBD, which enriched fiber, modulate the fecal microbiota metabolites, alter study participants’ serum metabolome. Correlative studies offer insight into impact nutrition metabolic pathways are known be affected by PC, and/or excess steroid metabolism, ketogenesis, fatty acid metabolism. Methods: Key eligibility criteria include pts BMI ≥ 27 receiving LHRH/GnRH analogue for >24 weeks pre-study (+ androgen receptor pathway inhibitor >3 mos) anticipation >26 more ADT. 60 randomized 1:1 between two cohorts. Cohort 1: receive 12 prepared meals (provided Plantable) per 1-4 6 5-8 plus Plantable coaching, nutritional counseling education assist self-prepping plant-based (weeks 9-26); 2 (control): general from Registered Dietician weekly 8 weeks, then monthly x 4. Collection baseline serial measurements (pre-intervention, 4, 26) weight, carotenoid levels (to monitor dietary compliance), dual energy x-ray absorptiometry (DXA) scans, MnSOD polymorphisms, inflammation The primary comparison at 4 (with 80% power detect effect size 0.74 standard deviations 2-sided significance level 0.05 using two-sample t-test). Secondary objectives assess compare changes in: a) disorders (Hemoglobin A1c, fasting insulin/glucose) (LDL cholesterol, HDL triglycerides); b) pro-inflammatory markers (IL-6, hsCRP) adipokines (leptin, adiponectin); c) microbiota; d) quality life measurements. Exploratory metabolomics clonal hematopoiesis. Trial open Weill Cornell Medicine (WCM), John Hopkins University Columbia University. First pt enrolled WCM September 2022. Funding support Prostate Cancer Foundation; Clinical Trials Consortium c22-301. trial information: NCT05471414 .