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

NCT00989339 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2014-07-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Twenty-four Hour TPN and Saline Infusion

Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989339 on ClinicalTrials.gov