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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00989339
• Other study ID #: IRB00019153
• Secondary ID: IRB00019153
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 2, 2009
• Last updated: July 2, 2014
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Obesity

Intervention

Drug:
• Twenty-four Hour TPN and Saline Infusion
Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American Diabetes Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function		1 year	No
Secondary	oxidative stress		1 year	No
Secondary	autonomic nervous system		1 year	No
Secondary	insulin sensitivity		1 year	No
Secondary	carbohydrate metabolism		1 year	No