Prevention of urinary tract infection with Oximacro®, a cranberry extract with a high content of A-type Proanthocyanidins (PAC-A). A pre-clinical double-blind controlled study.

Purpose: 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. Materials and Methods: The Oximacro® PACs content was assayed using the BL-DMAC method, and the dimer and trimer PACs-A and PACs-B percentages were determined via 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, CFU/mL counts from the urocultures 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.