Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers

Study Overview
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Brief Summary
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Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of fat approved by the FDA for clinical use. It is usually used as nutrition support in malnourished patients. The investigators' preliminary studies indicate that Intralipid results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil intravenous (IV) on blood pressure and inflammation is not known. In this study, the investigators will compare the effect of Intralipid and olive oil on blood pressure, blood vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that Olive oil emulsions will result in less vascular changes and less inflammatory response than Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function (vascular stiffness), inflammation in normal subjects. A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions. Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20 ml/hour for 24 hours.

Official Title
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Effects of Intralipid and Olive Oil Infusion on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism

Conditions
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Diabetes, Hypertension, Obesity

Intervention / Treatment
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* Drug: Twenty-four Hour TPN and Saline Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females BMI 25 -35 kg/m2, between the ages of 18 and 65 years BP < 140/80 mm Hg and no prior history of hypertension Exclusion Criteria: Pregnancy or breast feeding 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twenty-four Hour TPN and Saline Infusion<br>Subjects will be admitted to the Grady research center on the evening before each study. The next morning, after an overnight fast, they will receive, in random order, Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr. The interval between admissions will be 1 month. | Drug: Twenty-four Hour TPN and Saline Infusion<br>* Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress |  | 1 year | 
| autonomic nervous system |  | 1 year | 
| insulin sensitivity |  | 1 year | 
| carbohydrate metabolism |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipid emulsion, endothelial function, inflammatory markers, oxidative stress, insulin sensitivity, carbohydrate metabolism