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NCT01232309 · ClinicalTrials.gov registry record · NA
Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
A NA study of Cardiovascular, sponsored by Stratum Nutrition.
- Completed
- Registry status
- NA
- Development phase
- 135
- Enrollment target
- 3
- Study locations
NCT01232309: Completed NA study of Cardiovascular, sponsored by Stratum Nutrition.
NCT01232309 is a NA study of Cardiovascular that has completed, run by Stratum Nutrition. The registered enrollment target is 135 participants, below the 237-participant average among 8 other Cardiovascular trials with a reported enrollment target (43% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01232309, a NA study of Cardiovascular, has completed, sponsored by Stratum Nutrition.
- COMPLETED
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
- 3
- Study locations
Study Summary
Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides, and low high-density lipoprotein (HDL)-cholesterol. Elevated "oxidized" LDL, a pro-inflammatory villain, has also emerged as an important risk factor for the development of CVDs. There is a growing need to identify safe and effective nutritional interventions that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from many studies in humans have shown various health benefits provided by dietary fiber intake, including an inverse association with the risk of developing cardiovascular disease. The primary purpose of this study is to determine whether daily consumption for 6 weeks of chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan on other cardiovascular risk factors will also be evaluated.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Chitin-Glucan
- DIETARY_SUPPLEMENT Low Dose Chitin-Glucan
- DIETARY_SUPPLEMENT Low Dose Chitin-Glucan + Olive Extract
Study Locations (3)
Illinois
- Provident Clinical Research and Consulting - Addison
Kentucky
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC) - Louisville
Ontario
- KGK Synergize - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT01232309 record still lists
NCT01232309 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 237-participant average among 8 other Cardiovascular trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Cardiovascular appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01232309 reports a single indexed study location in Illinois, Kentucky, Ontario.
Frequently Asked Questions
What is clinical trial NCT01232309 about?
NCT01232309 is a clinical study titled "Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)". Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides, and low high-density li...
What is the current status of trial NCT01232309?
This trial is currently completed. It is a NA study. The enrollment target is 135 participants. The study started on 2010-08. Estimated completion is 2011-01.
What conditions does trial NCT01232309 study?
This clinical trial studies the following conditions: Cardiovascular.
What interventions are being tested in trial NCT01232309?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Chitin-Glucan (DIETARY_SUPPLEMENT), Low Dose Chitin-Glucan (DIETARY_SUPPLEMENT), Low Dose Chitin-Glucan + Olive Extract (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01232309?
This trial is sponsored by Stratum Nutrition, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01232309 being conducted?
This trial has 3 study locations across Illinois, Kentucky, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01232309's enrollment target sits among peer trials
135 4th of 8 higher than 5 of 8 other Cardiovascular trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular 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.
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