CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Alpha cyclodextrin +1 moredrug
Likely dose
Alpha cyclodextrin 2gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01131299
NCT01131299Phase 2Completed

Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted May 26, 2010·Updated Oct 21, 2016

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.1 years ago

Interventions

Placeboother

2 tablets PO 3 times a day for 12-14 weeks

Alpha cyclodextrindrug

2g PO 3 times a day for 12-14 weeks