Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Completed · Phase 2/Phase 3
Conditions studied: Diseases, Metabolic, Insulin Sensitivity
In brief
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.
Key facts
- Study ID
- NCT02185729
- Run by
- Emory University
- People needed
- 12
- Starts
- 2008-06-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-12-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years
You may not qualify if…
- The patient is pregnant or breast feeding
- Subjects have or with history of diabetes, hypertension, fasting triglyceride levels > 250 mg/dL, liver disease (ALT 2.5x > upper limit of normal), serum creatinine ≥1.5 mg/dL
- Smokers or ex-smoker < 3 months of cessation, drug or alcohol abuse
- Mental condition rendering the subject unable to understand the scope and possible consequences of the study.
Where it is running
- Grady Memorial Hospital — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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