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

NCT ID: NCT02185729

Last Updated: 2014-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diseases, Metabolic Insulin Sensitivity

Keywords

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Intravenous Feeding Lipid Emulsions, Intravenous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Intralipid

Intervention Type DRUG

Infusion of Intralipid (soybean-derived fat)

ClinOleic

Intervention Type DRUG

Infusion of ClinOleic (olive oil-based)

Dextrose

Intervention Type DRUG

Infusion of dextrose (sugar) without fat

Saline (control)

Intervention Type OTHER

Infusion of 0.9% normal saline

Interventions

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Intralipid

Infusion of Intralipid (soybean-derived fat)

Intervention Type DRUG

ClinOleic

Infusion of ClinOleic (olive oil-based)

Intervention Type DRUG

Dextrose

Infusion of dextrose (sugar) without fat

Intervention Type DRUG

Saline (control)

Infusion of 0.9% normal saline

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Guillermo Umpierrez

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Siqueira J, Smiley D, Newton C, Le NA, Gosmanov AR, Spiegelman R, Peng L, Osteen SJ, Jones DP, Quyyumi AA, Ziegler TR, Umpierrez GE. Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects. J Clin Endocrinol Metab. 2011 Oct;96(10):3207-16. doi: 10.1210/jc.2011-0480. Epub 2011 Aug 10.

Reference Type RESULT
PMID: 21832112 (View on PubMed)

Other Identifiers

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IRB00007543

Identifier Type: -

Identifier Source: org_study_id