NCT02185729

Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diseases, Metabolic
• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	Intralipid	Infusion of Intralipid (soybean-derived fat)
DRUG	ClinOleic	Infusion of ClinOleic (olive oil-based)
DRUG	Dextrose	Infusion of dextrose (sugar) without fat
OTHER	Saline (control)	Infusion of 0.9% normal saline

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2014-07-10
• Last updated: 2014-12-31
• Results posted: 2014-12-31

Locations

1 site across 1 country: United States