Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in Healthy Volunteers and ICU Patients (TPN)

For the healthy volunteer study:

Inclusion Criteria:

• Healthy males or females, BMI 25 -35 kg/m2, between the ages of 18 and 65 years.

Exclusion Criteria:

• 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.

For the ICU study:

Inclusion criteria:

• Age: 18 - 80 years when initiating PN
• In medical/surgical ICU
• Has central venous access to administer PN
• Anticipated to receive PN ≥ 5 days

Exclusion criteria:

• Enrolled in an investigative study within the last 30 days prior to study entry
• Female patients: pregnant or breast feeding
• Has clinical sepsis (defined as mean arterial pressure (MAP) < 60 mmHg on ≥ 2 occasions and unstable BP despite pressor support) within 24 hours prior to study entry
• Has known cirrhosis or total bilirubin ≥ 10.0 mg/dL
• Has chronic renal failure (defined as requirement for hemodialysis or peritoneal dialysis therapy), or creatinine ≥ 3.5 mg/dL without CRRT, or requires acute post-operative dialysis
• Has an active malignancy (defined as requiring chemotherapy, radiation, and/or surgical intervention within 90 days prior to study entry) (excluding non-melanoma skin cancer)
• Has known AIDS
• Has a terminal illness (life expectancy < 7 days)
• Has undergone organ transplantation
• Has received PN with lipid within 48 hours prior to study entry
• Has mental disability to understand the scope and possible consequences of the study and the legally authorized representative is unavailable
• Has a baseline serum triglyceride > 400 mg/dL