title: Safety and adherence of Umezu polyphenols in the Japanese plum (Prunus mume) in a 12-week double-blind randomized placebo-controlled pilot trial to evaluate antihypertensive effects.
abstract: OBJECTIVE
  Medications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension. Capsules including Umezu polyphenols (UP), polyphenols in Japanese plums, may help them to control their blood pressure (BP). The aim of this study is to evaluate the effectiveness of UP on BP and its safety.
  
  
  METHODS
  A total of 15 healthy workers without antihypertensive medication who had some concerns about their BP, preferably normal-high BP or hypertension level 1, were randomized in a double-blind manner into UP ingesting and placebo groups. Each subject was instructed to take four capsules daily for 12 weeks (daily UP dose, 800 mg for the UP ingesting group; and 0 mg for the placebo group). These subjects were followed for 12 weeks, and their BP both at home and at the examination site, as well as self-perceived quality-of-life outcomes and possible side effects, was monitored during that period. Group × time interactions on BP changes were examined.
  
  
  RESULTS
  All of the 15 subjects completed the 12-week intervention trial. The BP changes did not significantly differ between the UP ingesting and placebo groups, neither at the examination site nor at home. But during the study period, no adverse effects were observed.
  
  
  CONCLUSIONS
  No remarkable effect of UP on BP was observed. However, a higher dose of UP was confirmed safe and high in adherence in this 12-week randomized controlled trial. Its effect on BP and other outcomes shall be confirmed in a larger sample.
authors.affiliation: Department of Hygiene, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan, steakmmi@hotmail.com.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Takemura
authors.forename: Kouichi
authors.initials: K
authors.lastname: Yoshimasu
authors.forename: Jin
authors.initials: J
authors.lastname: Fukumoto
authors.forename: Kanae
authors.initials: K
authors.lastname: Mure
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Nishio
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Kishida
authors.forename: Fumiko
authors.initials: F
authors.lastname: Yano
authors.forename: Takahiko
authors.initials: T
authors.lastname: Mitani
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Takeshita
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Miyashita
mesh_terms: D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007564:Japan; D008297:Male; D055118:Medication Adherence; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D059808:Polyphenols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D027861:Prunus / Q000737:chemistry*; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts; D059808:Polyphenols