Status:
COMPLETED
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Lead Sponsor:
Emory University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Diseases, Metabolic
Insulin Sensitivity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02185729
Start Date
June 1 2008
End Date
March 1 2012
Last Update
December 31 2014
Active Locations (1)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303