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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 is a NA study of Cardiovascular Disease that has completed, run by Penn State University. The registered enrollment target is 20 participants, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Palm DAG Oil

Study Locations (1)

Pennsylvania

  • Penn State University - University Park

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-02
Est. Completion 2009-11
Phase NA

Sponsor

Penn State University

219 total trials

What the Registry Record Tells You About NCT00937963

The ClinicalTrials.gov registry entry for NCT00937963 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (99% lower). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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