JPRN‐UMIN000023274.

Study name	A clinical trial to investigate the effect of the foods containing plant extract
Methods	Double‐blind randomized controlled trial
Participants	Inclusion criteria: men aged 50 to 80 giving written informed consent Key exclusion criteria: Serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system Previous medical history of drug or food allergy, or both Constant use of oral medicines, functional foods and/or supplements Ineligible due to the physician's judgment Participation in other clinical trials
Interventions	Intervention: food containing plant extract for 8 weeks Control: food without plant extract for 8 weeks
Outcomes	Primary outcomes Change from baseline of IPSS total score at 4‐ and 8‐week consumption Key secondary outcomes Change from baseline of IPSS2 score at 4‐ and 8‐week consumption Change from baseline of BPH Impact Index total score at 4‐ and 8‐week consumption Change from baseline of PSA at 8‐week consumption
Starting date	23 July 2016
Contact information	Masayuki Sugimoto Email: info.food@kb‐clinic.com Takashi Sone Email: t.sone@kb‐clinic.com (contacted both on 30 December 2022)
Notes