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

Phase 2

Withdrawn

• Conditions: Diabetes; Hypertension; Obesity
• Interventions: Drug: Twenty-four Hour TPN and Saline Infusion

• Registration Number: NCT00989339
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Study First Posted: 2009-10-05
• Study Start: 2009-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twenty-four Hour TPN and Saline Infusion	Twenty-four Hour TPN and Saline Infusion	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.

Primary Outcome Measures

Name	Time	Method
endothelial function	1 year

Secondary Outcome Measures

Name	Time	Method
autonomic nervous system	1 year
oxidative stress	1 year
insulin sensitivity	1 year
carbohydrate metabolism	1 year