Metabolic Response to Omega-3 Fatty Acids and Vitamin E Co-Supplementation in Patients with Fibrocystic Breast Disease: A Randomized, Double-Blind, Placebo-Controlled Trial

Background: There is scarce data on the effects of omega-3 fatty acids and vitamin E co-supplementation on metabolic status in patients with fibrocystic breast disease (FBD). The current study was carried out to determine the effects of omega-3 fatty acids and vitamin E co-supplementation on metabolic status in patients with FBD. Methods: A randomized clinical trial was conducted on 56 patients with FBD. Participants were randomly divided into two groups to receive either 1000 mg omega-3 fatty acids plus 400 mg vitamin E (n = 28) or placebo (n = 28) for 12 weeks. Fasting blood samples were taken at the beginning of the study and after 12 weeks of intervention to determine inflammatory factors, biomarkers of oxidative stress, and metabolic profiles. Results: After 12 weeks of intervention, changes in serum high-sensitivity C-reactive protein (-2171.4 +/- 3189.1 vs. +696.9 +/- 2774.8 ng/mL, P = 0.001) and plasma nitric oxide (+1.8 +/- 4.0 vs.-0.1 +/- 2.4 pmol/L, P = 0.04) in supplemented women were significantly different from those in the placebo group. In addition, compared to the placebo group, subjects who consumed omega-3 fatty acids plus vitamin E supplements had significantly decreased serum insulin concentrations (-3.2 +/- 6.5 vs.-0.2 +/- 1.7 mu U/mL, P = 0.01), the homeostasis model of assessment-estimated insulin resistance (-0.8 +/- 1.7 vs.-0.02 +/- 0.4, P = 0.03), serum triglycerides levels (-11.5 +/- 47.3 vs. +10.6 +/- 24.3 mg/dL, P = 0.03) and VLDL-cholesterol (-2.3 +/- 9.5 vs. +2.1 +/- 4.9 mg/dL, P = 0.03), as well as increased quantitative insulin sensitivity check index (+0.01 +/- 0.01 vs. +0.001 +/- 0.007, P = 0.001) and HDL-cholesterol (+3.4 +/- 6.0 vs.-1.3 4.3 mg/dL, P = 0.001). Conclusion: Overall, omega-3 fatty acids and vitamin E co-supplementation for 12 weeks had beneficial effects on inflammatory markers and metabolic profiles in patients with FBD.