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

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 hea...

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Bibliographic Details
Published in:Asian journal of andrology 2009-05, Vol.11 (3), p.385-392
Main Authors: López, Ernesto, Molina, Vivian, Illnait, José, Oyarzábal, Ambar, Fernández, Lilia C, Más, Rosa, Gámez, Rafael, Fernández, Julio C, Jiménez, Sonia, Mesa, Meilis, Hollands, Ivón, Mendoza, Sarahí
Format: Article
Language:English
Subjects:
Adult
Antioxidants - administration & dosage
Antioxidants - adverse effects
Arecaceae
Biomarkers - blood
Humans
Lipid Peroxidation - drug effects
Lipids
Male
Middle Aged
Original
Oxidative Stress - drug effects
Placebos
Plant Extracts - administration & dosage
Plant Extracts - adverse effects
Prostatic Hyperplasia - drug therapy
Prostatic Hyperplasia - metabolism
Young Adult
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Summary: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
ISSN:1008-682X
1745-7262
DOI:10.1038/aja.2008.34