Effects of d-003 (10 mg/day) and fatty acids omega-3 on the life quality in post-menopausal women on osteoporotic risk

Abstract

D-003 is a mixture of high molecular weight fatty acids from sugar cane (Saccharum Officinarum L), it reduces bone resorption markers and improves bone density in ovariectomized rats and in postmenopausal women, in which life quality was improved. The objective of the present study was to investigate whether the combined therapy D-003 (10 mg / d) +Omega-3 (1 g/d) provides some additional benefit on quality of life in postmenopausal women. In a randomized, double-blind study, one group received D-003+Omega-3 and the other group received Placebo+Omega-3. The Qualeffo Questionnaire 41 was used to assess the Quality of life. Safety was assessed by physical examination and blood chemistry as well as by adverse events during the study. Both treatments significantly improved the overall score of the Questionnaire (combined therapy: 16.6 % and Omega-3 monotherapy: 21.1 %, vs baseline values p < 0.001). Particularly, mental status improved 9.4 % for group combined therapy and 4.5 % for group Omega-3 monotherapy (p < 0.05). HDL-C increased by 12.2 % (p < 0.01), in group combined therapy and 8.2 % in Omega-3 monotherapy. The triglycerides decreased 12.7 % in group combined therapy with D-003+Omega-3, with no change in group Omega-3 monotherapy. Both treatments were well tolerated. It is concluded that D-003 (10 mg/d) +Omega-3 (1 g/d) combination therapy and Omega-3 monotherapy administered during three months presented similar efficacy, safety and tolerability in postmenopausal women at moderate to high osteoporosis risk, and so, the combination therapy it not show additional advantages respect Omega-3 monotherapy on life quality in these patients. Furthers studies has been necessary to confirm these results.