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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: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.
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 |
What the finished NCT01131299 record still lists
NCT01131299 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01131299 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131299's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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