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NCT Number: NCT02185729

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

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.

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Key information

Conditions

Diseases, Metabolic Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intralipid

Drug

Infusion of Intralipid (soybean-derived fat)

Clinoleic

Drug

Infusion of ClinOleic (olive oil-based)

Dextrose

Drug

Infusion of dextrose (sugar) without fat

Saline (control)

Other

Infusion of 0.9% normal saline

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Acronym: TPN1

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2014
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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