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Trial record 67 of 180 for:    Phospholipids

Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers (TPN1)

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ClinicalTrials.gov Identifier: NCT02185729
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Brief Summary:
Many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions. The investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. This study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. The investigators will also compare the effect of different fats (olive oil and soybean) in the TPN solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.

Condition or disease Intervention/treatment Phase
Diseases, Metabolic Insulin Sensitivity Drug: Intralipid Drug: ClinOleic Drug: Dextrose Other: Saline (control) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomized Study Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion: Effects on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism
Study Start Date : June 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Volunteer
Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
Drug: Intralipid
Infusion of Intralipid (soybean-derived fat)

Drug: ClinOleic
Infusion of ClinOleic (olive oil-based)

Drug: Dextrose
Infusion of dextrose (sugar) without fat

Other: Saline (control)
Infusion of 0.9% normal saline




Primary Outcome Measures :
  1. Flow Mediated Dilation [ Time Frame: Baseline ]
    Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.

  2. Flow Mediated Dilation [ Time Frame: 4 hours after infusion ]
    Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 4 hour diameter)/4 hour diameter × 100.

  3. Flow Mediated Dilation [ Time Frame: 24 hours after infusion ]
    Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 24 hour diameter)/24 hour diameter × 100.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years

Exclusion Criteria:

  • The patient is pregnant or breast feeding
  • Subjects have or with 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185729


Locations
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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Guillermo Umpierrez, MD Emory University

Publications of Results:
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Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02185729     History of Changes
Other Study ID Numbers: IRB00007543
First Posted: July 10, 2014    Key Record Dates
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Guillermo Umpierrez, Emory University:
Intravenous Feeding
Lipid Emulsions, Intravenous

Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Diseases
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions