title: Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 < 0.045) for subjects on α-CD versus placebo. Fasting plasma glucose (1.6 %, p < 0.05) and Insulin resistance index (11 %, p < 0.04) were also decreased when on α-CD versus placebo.
  
  
  CONCLUSIONS
  α-CD treatment appears to be safe and well tolerated in healthy individuals and showed a modest reduction in small LDL particles, and an improvement in glucose related parameters.
  
  
  BACKGROUND
  NCT01131299.
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA. ma90x@nih.gov.
authors.forename: Marcelo J A
authors.initials: MJ
authors.lastname: Amar
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
authors.forename: Maryann
authors.initials: M
authors.lastname: Kaler
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
authors.forename: Amber B
authors.initials: AB
authors.lastname: Courville
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Shamburek
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
authors.forename: Maureen
authors.initials: M
authors.lastname: Sampson
authors.affiliation: Lipoprotein Metabolism Section, Cardio-Pulmonary Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 8 N-228, 10 Center Drive MSC 1666, Bethesda, MD, USA.
authors.forename: Alan T
authors.initials: AT
authors.lastname: Remaley
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D008076:Cholesterol, HDL / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood*; D004043:Dietary Fiber / Q000008:administration & dosage*; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance / Q000502:physiology; D008297:Male; D008875:Middle Aged; D014280:Triglycerides / Q000097:blood*; D047391:alpha-Cyclodextrins / Q000008:administration & dosage*
chemical_list: D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004043:Dietary Fiber; D007328:Insulin; D014280:Triglycerides; D047391:alpha-Cyclodextrins; C032613:alpha-cyclodextrin
keywords: BAS; Bile acid sequestrants; HDL-C; High density lipoprotein cholesterol; LDL-C; LIRI; Lipoprotein Insulin Resistance Index; Low density lipoprotein cholesterol; TC; TG; Total cholesterol; Triglycerides; α-cyclodextrin