Efficacy and Safety of a Proprietary Free Fatty Acid Rich Saw Palmetto Extract (USPlus® PRO) for Lower Urinary Tract Symptoms in Males: A Randomized, Double-Blind, Placebo-Controlled Trial

Background: Lower urinary tract symptoms (LUTS) affect most men aged 50+ and can significantly impair quality of life. Saw palmetto extracts have been evaluated for LUTS with mixed results, likely due to differing extraction quality, dosing, and study design. This study aimed to evaluate the efficacy and safety of USPlus PRO saw palmetto extract on LUTS in males. Methods: This randomized, placebo-controlled trial enrolled 80 males aged 45 - 80 years with LUTS. Participants were randomized 1:1 to two daily 160 mg USPlus PRO soft gels (providing 240 mg free fatty acids) or matched placebo for 12 weeks. Primary outcomes included changes in International Prostate Symptom Score (IPSS) and urinary frequency. Secondary outcomes included Brief Sexual Function Inventory (BSFI), quality of life, liver function, and safety. Results: Data from 62 participants were analyzed (USPlus PRO n = 30; Placebo n = 32). At Week 12, a statistically significant between group difference in IPSS total score was observed (p = 0.047). A clinically meaningful IPSS response (≥25% reduction) was evident in the USPlus PRO group by week 4. At week 12, statistically significant improvements were observed in the USPlus PRO group for the IPSS voiding subscore (IPSS-V) (p = 0.027), incomplete emptying (p = 0.002), weak stream (p = 0.026), BSFI total scores (p = 0.041), and erection domain scores (p = 0.039). Safety outcomes were comparable between groups. Conclusions: USPlus PRO saw palmetto extract provided significant, clinically meaningful improvements in LUTS, notably voiding symptoms, incomplete emptying, and weak stream over 12 weeks. Furthermore, significant improvements in sexual function were found. USPlus PRO demonstrated a favorable safety profile and may be a beneficial treatment option for LUTS (Clinical Trial ID NCT06266000).