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

NCT ID: NCT00989339

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Diabetes; Hypertension; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Twenty-four Hour TPN and Saline Infusion

Intervention Type: DRUG

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

Interventions

Twenty-four Hour TPN and Saline Infusion

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB00019153

Identifier Type: -

Identifier Source: secondary_id

IRB00019153

Identifier Type: -

Identifier Source: org_study_id