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

NCT02185729 | Completed Phase 2 Results DMC

• 1 other identifier: IRB00007543
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diseases, Metabolic; Insulin Sensitivity

Keywords

Intravenous Feeding; Lipid Emulsions, Intravenous

Outcome Measures

Primary Outcomes (3)

• Flow Mediated Dilation

  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.

  Baseline

• Flow Mediated Dilation

  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.

  4 hours after infusion

• Flow Mediated Dilation

  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.

  24 hours after infusion

Study Arms (1)

Healthy Volunteer

ACTIVE COMPARATOR

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; Drug: ClinOleic; Drug: Dextrose; Other: Saline (control)

Interventions

Intralipid DRUG

Infusion of Intralipid (soybean-derived fat)

Healthy Volunteer

ClinOleic DRUG

Infusion of ClinOleic (olive oil-based)

Healthy Volunteer

Dextrose DRUG

Infusion of dextrose (sugar) without fat

Healthy Volunteer

Saline (control) OTHER

Infusion of 0.9% normal saline

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

• 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.

  PMID: 21832112 RESULT

MeSH Terms

Conditions

Metabolic Diseases; Insulin Resistance

Interventions

soybean oil, phospholipid emulsion; ClinOleic; Glucose; Sodium Chloride

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Short duration and involved healthy volunteers--not clear whether the use of olive oil-based lipid emulsions may result in improved clinical outcomes over traditional lipid emulsions in hospitalized patients with medical and surgical illness.

Results Point of Contact

• Title: Guillermo Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: June 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 31, 2014
• Results First Posted: December 31, 2014

Record last verified: 2014-12

Locations

US (1)