

























































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


	










