Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

Summary

Background: * Cardiovascular disease (CVD) is a leading cause of death in developed countries. Although statin-type drugs are currently the most effective therapeutic agents for reducing CVD risk. One possible complementary approach involves the use of soluble dietary fibers that are known to reduce blood cholesterol levels. However, analysis has shown that most soluble fibers reduce total cholesterol levels by relatively small amounts. * Alpha-Cyclodextrin (Alpha-CD), also sold in commerical form, is a soluble fiber derived from corn that is used as an ingredient in many foods, such as bread rolls, crackers, juices, and reduced fat spreads. It is added to food primarily as a fiber supplement but is also used to stabilize flavors, colors, vitamins, and fatty acids. Studies in animals and humans have shown that Alpha-CD may help to improve insulin resistance and lower LDL cholesterol levels with no apparent side effects. More research is needed to determine the effect of Alpha-CD on total cholesterol levels in healthy volunteers. Objectives: \- To determine the effect of oral Alpha-CD on total cholesterol in a nondiabetic population.

Timeline

Start

2010-03

Primary completion

2015-02

Completion

2015-02

Publications

• Background Fedder DO, Koro CE, L'Italien GJ. New National Cholesterol Education Program III guidelines for primary prevention lipid-lowering drug therapy: projected impact on the size, sex, and age distribution of the treatment-eligible population. Circulation. 2002 Jan 15;105(2):152-6. doi: 10.1161/hc0202.101971.
• Background Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
• Background Shepherd J. Dyslipidaemia in diabetic patients: time for a rethink. Diabetes Obes Metab. 2007 Sep;9(5):609-16. doi: 10.1111/j.1463-1326.2006.00642.x.
• Amar MJ, Kaler M, Courville AB, Shamburek R, Sampson M, Remaley AT. Randomized double blind clinical trial on the effect of oral alpha-cyclodextrin on serum lipids. Lipids Health Dis. 2016 Jul 12;15(1):115. doi: 10.1186/s12944-016-0284-6.

Drugs

Indications