We assessed treatment compliance and addressed adverse experiences (AEs) at weeks 3 and 6. Oxidative variables included plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), sulphydryl (SH) groups and total antioxidant status (TAS). Physical examinations were performed at each visit, and laboratory tests were performed at baseline and at treatment completion. An interim check-up and a final visit were conducted after 3 and 6 weeks of therapy, respectively. Thirty-four eligible participants were randomized to placebo or D-004 (320 mg) capsules administered daily for 6 weeks. We enrolled male volunteers (20-55 years) in good health and without lower urinary tract symptoms.
The aim of this study was to conduct a randomized, double-blind and placebo-controlled study to investigate the effects of D-004, a lipid extract of the Roystonea regia fruit that prevents testosterone- and phenylepinephrine-induced prostate hyperplasia in rodents, on plasma oxidative markers in healthy men.
Further studies should investigate whether D-004 also exhibits antioxidant effects in vivo. Nevertheless, this study shows only in vitro results. Since increased oxidative stress has been linked to PH, the antioxidant effect of D-004 shown here could contribute to explaining its beneficial effects on T-induced PH in rodents. D-004 also inhibited lipooxygenase (LOX) and cyclooxygenase (COX) activities, and the generation of protein-associated carbonyl groups after LP. Also, D-004 inhibited CCl4-mediated LP in active liver microsomes through a decreased generation of radical species rather than a radical trapping action on CCl(4)-derived radical species. D-004 showed hydroxyl radical scavenging activity, which could explain partially its antioxidant effect on microsomal iron-induced LP, but it was unable to scavenge superoxide and ABTS radicals, indicating a limited radical scavenging activity. D-004 (0.9-1000 microg/mL) markedly and dose-dependently inhibited in vitro iron-induced LP in native brain and liver microsomes. Since fatty acids inhibit lipid peroxidation (LP), this study investigated whether D-004 prevents in vitro LP. D-004 inhibits prostate hyperplasia (PH) induced with testosterone, in rodents. D-004 is a lipid extract of the fruits of the Cuban royal palm (Roystonea regia) containing a mixture of saturated fatty acids.
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