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NCT00937963 · ClinicalTrials.gov registry record · NA
Healthy Fatty Acids in Transition
A NA study of Cardiovascular Disease, sponsored by Penn State University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00937963: Completed NA study of Cardiovascular Disease, sponsored by Penn State University.
NCT00937963 is a NA study of Cardiovascular Disease that has completed, run by Penn State University. The registered enrollment target is 20 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00937963, a NA study of Cardiovascular Disease, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Diacylglycerol (DAG) is a molecule that consists of two fatty acid chains bound by ester links to a glycerol molecule, in the form of 1,2 and 1,3 structural isomers. Approximately 10% of the edible oils on today's market are comprised from DAG. DAG oil has a similar taste, appearance, and fatty acid composition as conventional triacylglycerol oil (TAG; consists of 3 fatty acids chains bound to a glycerol molecule), yet recent studies suggest that due to its different chemical structure, DAG oil may induce cardiovascular (CV) benefits. Specifically, human studies in the United States (US) and Japan have shown that long-term consumption of a diet containing DAG oil enhances loss of body weight and body fat compared with TAG oil of similar fatty acid composition. In postprandial studies, serum triglycerides (TG) and remnant like particle cholesterol concentrations, have shown to be lower following ingestion of DAG-enriched oil compared to conventional dietary oil (e.g., soybean, corn), or TAG oil. Therefore, DAG oil appears to be effective for preventing postprandial hyperlipidemia, which is a risk factor for arteriosclerosis. The hypothesis that the investigators propose in this pilot study is that intake of DAG oil, compared to TAG oil will result in a lower LDL-C, and lower LDL-C/HDL-C ratio, as well as a reduction in TG levels. Given the significance of such findings, if confirmed, the investigators will evaluate other important clinical biomarkers for chronic disease (CV Disease, type 2 diabetes, metabolic syndrome), such as insulin sensitivity and inflammation \[as determined by C-reactive protein (CRP), interleukin (IL)-1, IL-6 \& tumor necrosis factor-alpha (TNF-α)\], which also may be beneficially affected by consumption of the palm DAG oil. During the pilot study, the investigators will reserve serum/plasma samples so that these additional assays may be run upon approval of the modification.
Primary Outcome
Participants receive a two week break between diet periods. Diet period 1 runs from week 1-4 and diet period 2 from week 7-10.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Palm DAG Oil
Study Locations (1)
Pennsylvania
- Penn State University - University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-11 |
| Phase | NA |
What the finished NCT00937963 record still lists
NCT00937963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Palm DAG Oil is the first listed.
NCT00937963 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00937963 about?
NCT00937963 is a clinical study titled "Healthy Fatty Acids in Transition". Diacylglycerol (DAG) is a molecule that consists of two fatty acid chains bound by ester links to a glycerol molecule, in the form of 1,2 and 1,3 structural isomers. Approximately 10% of the edible oils on today's market are comprised from DAG. DAG oil has a similar taste, appearance, and fatty acid...
What is the current status of trial NCT00937963?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2009-02. Estimated completion is 2009-11.
What conditions does trial NCT00937963 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
What interventions are being tested in trial NCT00937963?
The interventions under investigation include: Palm DAG Oil (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00937963?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00937963 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00937963's enrollment target sits among peer trials
20 130th of 137 higher than 5 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease 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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