At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
In Brief
A Phase 2 clinical trial evaluating Placebo and Alpha cyclodextrin for Cardiovascular Disease. Completed, enrolled 103 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
2 tablets PO 3 times a day for 12-14 weeks
2g PO 3 times a day for 12-14 weeks