title: Prevention of Urinary Tract Infection with Oximacro, A Cranberry Extract with a High Content of A-Type Proanthocyanidins: A Pre-Clinical Double-Blind Controlled Study.
abstract: OBJECTIVE
  Urinary tract infections (UTIs) are widespread and affect a large portion of the human population. Cranberry juices and extracts have been used for UTI prevention due to their content of bioactive proanthocyanidins (PACs), particularly of the A type (PAC-A). Controversial clinical results obtained with cranberry are often due to a lack of precise determination and authentication of the PAC-A content. This study used Oximacro (Biosfered S.r.l., Turin, Italy), a cranberry extract with a high content of PAC-A, to prevent UTIs in female and male volunteers.
  
  
  METHODS
  The Oximacro PACs content was assayed using the Brunswick Laboratories 4-dimethylaminocinnamaldehyde (BL-DMAC) method, and the dimer and trimer PACs-A and PACs-B percentages were determined via high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (HPLC/ESI-MS/MS). A balanced group of female (ranging from 19 to over 51 years) and male volunteers (over 51 years) was divided into two groups. The experimental group received 1 capsule containing Oximacro (36 mg PACs-A) twice per day (morning and evening) for 7 days, and the placebo group was given the same number of capsules with no PACs.
  
  
  RESULTS
  Analysis of Oximacro revealed a high total PAC content (372.34 mg/g ± 2.3) and a high percentage of PAC-A dimers and trimers (86.72% ± 1.65). After 7 days of Oximacro administration, a significant difference was found between the placebo and Oximacro groups for both females (Mann-Whitney U-test = 875; P < .001; n = 60) and males (Mann-Whitney U-test = 24; P = .016; n = 10). When the female and male age ranges were analysed separately, the female age range 31-35 showed only slightly significant differences between the placebo and Oximacro groups (Mann-Whitney U-test = 20.5; P = .095; n = 10), whereas all other female age ranges showed highly significant differences between the placebo and Oximacro groups (Mann-Whitney U-test = 25; P = .008; n = 10). Furthermore, colony forming unit/mL counts from the urine cultures showed a significant difference (P < .001) between the experimental and the placebo groups (SD difference = 51688; df = 34, t = -10.27; Dunn-Sidak Adjusted P < .001, Bonferroni Adjusted P < .001).
  
  
  CONCLUSIONS
  Careful determination of the total PAC content using the BL-DMAC method and the authentication of PACs-A with mass spectrometry in cranberry extracts are necessary to prepare effective doses for UTI prevention. A dose of 112 mg Oximacro containing 36 mg PACs-A was found to be effective in preventing UTIs when used twice per day for 7 days.
authors.affiliation: Department of Life Sciences and Systems Biology, University of Turin, Via Quarello 15/A, Turin, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Occhipinti
authors.affiliation: Farmacia Antoniana, Viale Cesare Balbo, 3, 10040 San Gillio (TO), Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Germano
authors.affiliation: Department of Life Sciences and Systems Biology, University of Turin, Via Quarello 15/A, Turin, Italy.
authors.forename: Massimo E
authors.initials: ME
authors.lastname: Maffei
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D044945:Proanthocyanidins / Q000627:therapeutic use*; D053719:Tandem Mass Spectrometry; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000378:metabolism / Q000517:prevention & control*; D029799:Vaccinium macrocarpon; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D044945:Proanthocyanidins; C013221:proanthocyanidin