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NCT01131299 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT01131299 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 103 participants.
The verdict
NCT01131299, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Alpha cyclodextrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01131299
The ClinicalTrials.gov registry entry for NCT01131299 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01131299 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01131299 about?
NCT01131299 is a clinical study titled "Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol". 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 reduc...
What is the current status of trial NCT01131299?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2010-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01131299?
The interventions under investigation include: Placebo (OTHER), Alpha cyclodextrin (DRUG).
Who is sponsoring clinical trial NCT01131299?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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