Effect of D-003, a mixture of very high molecular weight aliphatic acids purified from sugarcane wax, on serum lipid peroxidation (LP) markers in elderly

Background: D-003 is a mixture of long-chain aliphatic primary acids purified from sugar cane wax with cholesterol-lowering and preventive effects on lipoprotein lipid peroxidation (LP) proven in experimental and clinical studies. Objectives: To investigate if D-003 favourably modifies LP markers on older individuals. Methods: This double-blinded, randomized, placebo-controlled study investigated the effects of D-003 (5 and 10 mg/d) administered for 8 weeks on serum LP markers of older individuals. We assessed the effects of D-003 on LP of LDL as primary variable, while effects on plasma total antioxidant status (TAS), malondialdehyde (MDA) levels and plasma antioxidant enzyme activities were also investigated. We investigated the effects on lipid profile. Fifty-one older individuals (40 women, 11 men) were randomized to placebo or D-003 (5 or 10 mg/d), tablets being taken once a day with evening meal for 8 weeks. Laboratory tests and physical examination were performed at baseline and after 4 and 8 weeks on therapy, whereas compliance and adverse experiences (AE) were assessed at weeks 4 and 8. Results: D-003 (5 and 10 mg/d) significantly increased (p < 0.05 and p < 0.01) lag phase by 24.7 % and 29.3 %, respectively, while decreased propagation rate (p< 0.05) by 22.7 % (5 mg/d) and 25.8 % (10 mg/d). D-003 (5 and 10 mg/d) increased (p < 0.01) TAS by 17.7% and 23.0%, respectively, but only the changes achieved with 10 mg/d were different from placebo (p < 0.05). D-003 at 10 mg/d, not at 5 mg/d, significantly lowered (p < 0.05) plasma levels of thiobarbituric acid reactive substances (TBARS). D-003 (5 or 10 mg/d) did not modify superoxide dismutase (SOD) and GPX (glutathione peroxidase) activities. Also, D-003 (5 and 10 mg/d) reduced significantly low-density lipoprotein-cholesterol (LDL-C), total cholesterol (TC), and increased high-density lipoprotein-cholesterol (HDL-C). D-003 (10 mg/d) also reduced modestly, but significantly triglycerides. No significant changes of LP or lipid profile occurred in placebo. Treatment was well tolerated. D-003 did not impair safety indicators. No subject withdrew from the study. Only 3 subjects (2 placebo, 1 D-003 5 mg/d) reported AE: the two placebo patients reported insomnia and acidity, respectively, while that treated with D-003 referred acidity. Conclusions: D-003 (5 and 10 mg/d) administered for 8 weeks to older subjects effectively prevented LP in older and favourable modified lipid profile parameters. The present results add new data on the antioxidant effects of D-003, including demonstration on a new population subset. However, this aspect deserves further investigation including studies with larger sample sizes, doses and treatment duration.