Impact of a whole-food plant-based diet (WFPBD) on weight and metabo-inflammation in men with prostate cancer (PC) receiving androgen deprivation therapy (ADT): A multi-center randomized control trial.

5098 Background: Obesity promotes a chronic inflammatory state associated with PC progression. ADT can cause weight gain, accumulation of body fat, insulin resistance and increased risk of diabetes and cardiovascular disease. A WFPBD promotes weight loss, decreases inflammation, and shifts the gut microbiome to promote insulin sensitivity. We hypothesized that a WFPBD and behavioral intervention will promote weight loss and a reduction in adiposity in overweight/obese patients with PC on ADT. Methods: Pts with PC with BMI ≥ 27 receiving ADT with an LHRH/GnRH analogue for >24 wks pre-study (+ AR pathway inhibitor allowed if stable dose for >3 mos) with plan >26 more wks were eligible. 60 patients were randomized 1:1. WFPBD group: 12 prepared and home delivered WFPBD meals per wks 1-4, 6 meals wks 5-8 and coaching to assist in self-prepping plant-based meals (wks 9-26); Control group: counseling on a general healthful diet from a Registered Dietician weekly for 8 wks, then monthly (wks 9-26). Baseline and serial measurements (pre-intervention, wks 4, 8 and 26): weight, body composition assessment via dual energy x-ray absorptiometry (DXA), and biomarkers of inflammation and metabolism were collected. Primary endpoint was weight loss at 4 weeks (with an 80% power to detect an effect size 0.74 standard deviations with a 2-sided significance level of 0.05 using a two-sample t-test). Secondary objectives were change in body composition, biomarkers of metabolic disorders and cardiovascular risk and quality of life measurements. Results: 60 pts were randomized (31 control, 29 WFPBD). Median age was 73; Race: 65% white, 28% Black, 2% Asian, 5% other/unknown; Median baseline weight 98 kg; No difference in baseline HbA1c or lipid profile between groups. Mean weight loss (kg) at 4, 8 and 26 wks: WFPBD: 3.9, 5.3 and 6.1 kg; Control 1.3, 1.6, 2.1 kg, respectively (each timepoint pair p<0.001). DXA measured BMI change at 4 and 26 wks: WFPBD: -1.1 and -1.93 kg/m 2 , Control: 0.35 and 0.25 kg/m 2 (each timepoint pair p<0.001). DXA measured mean lean (LM), fat (FM) and total mass (TM) showed declines at 4 wks in WFPBD versus Control (LM -2.4 vs -0.64 (p<0.001); FM -1.3 vs -0.35 (p=0.023); TM -3.61 vs -0.88 (p<0.001), whereas at 26 weeks only FM and TM remained significantly less (LM -2.2 vs -1.4 (p=0.143); FM -5.3 vs -0.8 (p=0.001); TM -6.7 vs -2.2 (p<0.001). No significant differences were seen in HbA1c or lipid profiles at 6 mos. Conclusions: Compared with nutritional counseling, obese men with PC on ADT subjected to a home-delivered WFPBD for 2 mos and behavioral coaching experienced significantly greater weight loss, BMI reduction and decreases in total and fat mass that persisted for 6 months. Biomarkers of metabo-inflammation, insulin levels, fecal microbiota and metabolites, and serum for metabolomics collected are undergoing analyses. Clinical trial information: NCT05471414 .