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


METHODS
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.


CONCLUSIONS
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.
Kobayashi
Koji
K
Division of Clinical Application, Department of Clinical Sciences, Institute of Natural Medicine, University of Toyama, 2630 Sugitani, Toyama-city, Toyama 9300194, Japan.
Hamazaki
Kei
K
Fujioka
Shuntaro
S
Terao
Keiji
K
Yamamoto
Junji
J
Kobayashi
Satoru
S
D000328:Adult; D000368:Aged; D019587:Dietary Supplements; D004311:Double-Blind Method; D004912:Erythrocytes / Q000737:chemistry; D005215:Fasting; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000032:analysis; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*; D047408:gamma-Cyclodextrins / Q000627:therapeutic use*
D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; D010743:Phospholipids; D014280:Triglycerides; D047408:gamma-Cyclodextrins