Antioxidant effects of D-004, a lipid extract from the Roystonea regia fruit, on the plasma of healthy men

Abstract

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. We enrolled male volunteers (20-55 years) in good health and without lower urinary tract symptoms. Thirty-four eligible participants were randomized to placebo or D-004 (320 mg) capsules administered daily for 6 weeks. An interim check-up and a final visit were conducted after 3 and 6 weeks of therapy, respectively. Physical examinations were performed at each visit, and laboratory tests were performed at baseline and at treatment completion. Oxidative variables included plasma malondialdehyde (MDA), total hydroxyperoxides (TOH), sulphydryl (SH) groups and total antioxidant status (TAS). We assessed treatment compliance and addressed adverse experiences (AEs) at weeks 3 and 6. At week 6, with D-004, the mean reductions of plasma MDA (26.7%), TOH (18.8%) and SH groups (31.6%), and the mean increase of TAS (35.3%) were significantly different from those of placebo (P<0.001 for plasma TAS, P<0.0001 for all other comparisons). D-004 did not differ from the placebo in safety indicators. There were two withdrawals (both in the D-004 group), with one due to dyspepsia (the only AE during the trial). In conclusion, D-004 displayed antioxidant effects on plasma oxidative markers in healthy men, which was consistent with findings from laboratory experimental studies.

Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)

“…The effect of D-004 on this variable, however, should not be interpreted as a proof of efficacy, as recent reports show controversial results of the use of this marker. The lack of effect of SP on this variable agrees with other reports [46].The treatments were well tolerated, consistent with previous data [25][26][27][28]40]. Safety indicators and sexual performance were not impaired by the treatments, which agree with previous reports on SP [11,12,46], and being the first report on this matter for D-004.…”

“…The present results are consistent with previous reports of the antioxidant effects of D-004 [25][26][27][28] and SP [28], and demonstrate, for the first time, that D-004 may decrease IPSS and to produce antioxidant effects in men with BPH that were comparable to those of SP. Both groups had similar baseline characteristics, so that they were homogeneous for comparisons.…”

“…SP capsules: caprylic 1.5%, capric 2.5%, lauric 29.9%, myristic 10.8%, palmitic 8.2%, palmitoleic 0.2%, stearic 1.9%, oleic + linoleic + linolenic 33.3%, with a purity of 88.4% The daily dosage (320 mg/day) was selected taken into account that D-004 (320 mg/day) administered for short-term reduced plasma MDA, TOH, SHG and increased TAS in healthy males [27,28], and the most common dose of SP used in different clinical studies [9][10][11][12]. D-004 and SP capsules, identical on appearance and packaged in identical codified containers, were given to the subjects according to their serial progressive inclusion.…”

“…Oral D-004 (320 mg/day) treatment for 6-8 weeks has been shown to reduce significantly plasma malondialdehyde (MDA), total hydroxyperoxides (TOH) and sulphydril groups (SHG), and to increase total antioxidant status (TAS) and catalase (CAT) activity in healthy men [27,28], effects similar to those produced by the same dose of SP extract [28]. No previous trial, however, had investigated the antioxidant effects of D-004 in patients with BPH.…”

Effects of Melandrium firmum methanolic extract on testosterone-induced benign prostatic hyperplasia in Wistar rats

“…[23][24][25] Various herbal extracts reduce oxidative stress in testosterone-induced BPH rats. [26][27][28][29] In addition, saw palmetto extract, which is commonly used to treat BPH, has shown antioxidant effects. 30 Therefore, antioxidants can be considered good candidates to suppress the development of BPH.…”