Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
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|ClinicalTrials.gov Identifier: NCT00989339|
Recruitment Status : Withdrawn (Sub-investigator left facility prior to study initiation)
First Posted : October 5, 2009
Last Update Posted : July 4, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hypertension Obesity||Drug: Twenty-four Hour TPN and Saline Infusion||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Effects of Intralipid and Olive Oil Infusion on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: 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.
Drug: Twenty-four Hour TPN and Saline Infusion
Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
- endothelial function [ Time Frame: 1 year ]
- oxidative stress [ Time Frame: 1 year ]
- autonomic nervous system [ Time Frame: 1 year ]
- insulin sensitivity [ Time Frame: 1 year ]
- carbohydrate metabolism [ Time Frame: 1 year ]