Clinical effect of phytosterol-enriched saw palmetto extract on urinary function in healthy middle-aged and older males: a double-blind, placebo-controlled randomized comparative study | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 14 No. 2 (2024): February 2024 / Research Articles Clinical effect of phytosterol-enriched saw palmetto extract on urinary function in healthy middle-aged and older males: a double-blind, placebo-controlled randomized comparative study Authors Tatsuya Hisajima Hideaki Waki Takuya Suzuki Takashi Izumi DOI: https://doi.org/10.31989/ffhd.v14i2.1312 Abstract Background: Saw palmetto extract (SPE) is one of the most widely used supplements for benign prostatic hyperplasia (BPH) due to its pharmacological effects. β-sitosterol-enriched saw palmetto oil (VISPO™) contains more than 3% β-sitosterol and 85% total fatty acids and has been shown to improve symptoms in patients with BPH. Lower urinary tract symptoms (LUTS) require primary preventive measures in countries with accelerated population aging, including Japan. VISPO™ is expected to be effective against the early symptoms of LUTS. However, the effect of VISPO™ on urinary function in healthy individuals has not been elucidated. Objective: This clinical study evaluated the efficacy and tolerability of VISPO™ in the management of urinary complaints among healthy middle-aged and older men who did not require treatment. Methods: We conducted a randomized, double-blind, placebo-controlled trial that included 54 male participants who were assigned to consume VISPO™ or placebo (olive oil) capsules for 12 weeks. Biometric data, uroflowmetry results, and salivary hormone levels were assessed at weeks 1 and 12. Urinary function and quality of life were assessed at weeks 1, 4, 8, and 12 using the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Core Lower Urinary Tract Symptom Score (CLSS), and WHOQOL-26. Results: Two-way analysis of variance revealed that IPSS and OABSS were significantly lower in the VISPO™ group that in the placebo group. However, there were no significant differences in urine volume, urinary flow rate, or salivary hormone levels. In addition, no participants reported adverse effects (diarrhea, abdominal pain, etc.).  Conclusion: The results of the present study, which is the first randomized controlled trial of VISPO™ conducted among healthy participants, demonstrate the effectiveness of VISPO™ in the management of lower urinary tract complaints that do not require treatment.  Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN000046386). Keywords: saw palmetto, VISPO™, β-sitosterol, fatty acids, healthy subjects, primary preventive, IPSS, OABSS, lower urinary tract symptoms (LUTS) Downloads [Abstract] [Full Article] Published 2024-02-09 Issue Vol. 14 No. 2 (2024): February 2024 Section Research Articles License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com