CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Intralipid +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02185729
NCT02185729Phase 3Completed

Randomized Study Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion: Effects on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism

Emory University·interventional·Posted Jul 10, 2014·Updated Dec 31, 2014

In Brief

A Phase 3 clinical trial evaluating Intralipid, ClinOleic, and 2 other interventions for Diseases, Metabolic and Insulin Sensitivity. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions. The investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. This study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. The investigators will also compare the effect of different fats (olive oil and soybean) in the TPN solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2014
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.0 years ago

Interventions

Intralipiddrug

Infusion of Intralipid (soybean-derived fat)

ClinOleicdrug

Infusion of ClinOleic (olive oil-based)

Dextrosedrug

Infusion of dextrose (sugar) without fat

Saline (control)other

Infusion of 0.9% normal saline