Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids

• Published in: Lipids in health and disease 2016-07, Vol.15 (1), p.115-115, Article 115
• Main Authors: Amar, Marcelo J A, Kaler, Maryann, Courville, Amber B, Shamburek, Robert, Sampson, Maureen, Remaley, Alan T
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adolescent; Adult; Aged; alpha-Cyclodextrins - administration & dosage; Blood Glucose - metabolism; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Dietary Fiber - administration & dosage; Double-Blind Method; Fasting; Female; Healthy Volunteers; Humans; Insulin - blood; Insulin Resistance - physiology; Male; Middle Aged; Triglycerides - blood
• ISSN: 1476-511X; 1476-511X
• DOI: 10.1186/s12944-016-0284-6

This single center, double-blinded, cross-over, placebo controlled clinical trial investigated the effect of oral α-cyclodextrin (α-CD), a soluble dietary fiber, on blood lipid and lipoprotein levels in healthy human subjects. α-CD, a cyclical polymer containing 6 glucose subunits, is currently sold as an over the counter food supplement and is also a common additive in many foods. α-CD forms a hydrophobic central cavity that binds lipids and has been shown in animal studies and in previous clinical trials to alter plasma lipid levels. We screened for healthy subjects, males and females, between ages 18 to 75. Out of total 103 subjects interviewed, 75 subjects completed the study. Qualified individuals in each gender group were randomized into two groups in terms of which treatment arm they received first (placebo vs. α-CD, receiving 6 grams P.O. a day, for 12-14 weeks with a 7 day wash out between arms). The primary outcome variable, plasma total cholesterol, as well as other tests related to lipids and lipoprotein and glucose metabolism, were measured at baseline and at the end of each arm of the study. α-CD was well tolerated; no serious adverse events related to α-CD were observed. Approximately 8 % of the subjects on α-CD complained of minor gastrointestinal symptoms versus 3 % on placebo (p = 0.2). Small-LDL particle number decreased 10 % (p