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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00989339
First received: October 2, 2009
Last updated: April 9, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Hypertension
Obesity
 Drug: Twenty-four Hour TPN and Saline Infusion
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • endothelial function [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative stress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • autonomic nervous system [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • carbohydrate metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989339

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
American Diabetes Association
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, MD, Emory University School of Medicine
ClinicalTrials.gov Identifier: NCT00989339     History of Changes
Other Study ID Numbers: IRB00019153, IRB00019153
Study First Received: October 2, 2009
Last Updated: April 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
lipid emulsion
endothelial function
inflammatory markers
 oxidative stress
insulin sensitivity
carbohydrate metabolism

Additional relevant MeSH terms:
Hypertension
Obesity
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013