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

Phase 2

Completed

Interventions: Drug: Intralipid
Drug: ClinOleic
Drug: Dextrose
Other: Saline (control)

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 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Healthy Volunteer	Saline (control)	Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
Healthy Volunteer	Intralipid	Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
Healthy Volunteer	ClinOleic	Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
Healthy Volunteer	Dextrose	Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilation	24 hours after infusion	Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - 24 hour diameter)/24 hour diameter × 100.

Secondary Outcome Measures