The effect of n - 3 PUFA/gamma-cyclodextrin complex on serum lipids in healthy volunteers--a randomized, placebo-controlled, double-blind trial.

OBJECTIVES This study was carried out to examine whether serum triglyceride concentrations were decreased by administration of n-3 polyunsaturated fatty acid (PUFA)/gamma-cyclodextrin (gamma-CD) complex-containing capsules as reported previously with n-3PUFA without gamma-CD. STUDY DESIGN A placebo-controlled double-blind study with healthy subjects (n=35) and hypertriglyceridemic subjects (n=7) of 35-66 years of age was performed. The subjects were randomized to a group (n-3 group) supplemented with n-3PUFA/gamma-CD-containing capsules (660 mg EPA + 280 mg DHA/day) or a control group supplemented with capsules containing essentially no n-3 PUFA for 8 weeks with stratification by sex, age, and serum triglyceride levels in a double blind manner. Fasting blood samples were obtained at the start of administration and 4 and 8 weeks afterward. RESULTS EPA concentrations in the total phospholipid fraction of red blood cells increased significantly in all subjects in the n-3 group, whereas no changes were seen in the control group. Triglyceride levels were significantly decreased (-17%) in the n-3 group compared with the control group at week 8. The following serum lipids did not significantly change over time: total-cholesterol, low-density lipoprotein-cholesterol and high-density lipoprotein-cholesterol. Only two subjects in the n-3 group guessed at the end of the study that their capsules were active. CONCLUSION n-3 PUFA/gamma-CD complex lowered triglyceride levels in normal and slightly hypertriglyceridemic subjects. There was a possibility that gamma-CD might at least partly cover the smell and aftertaste of fish oil.