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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Diseases, Metabolic
Insulin Sensitivity
Interventions Drug: Intralipid
Drug: ClinOleic
Drug: Dextrose
Other: Saline (control)
Enrollment 12
Recruitment Details All subjects seen at Grady Memorial Hospital Clinical Interactions Network unit of the Atlanta Clinical and Translational Science Institute. Subjects were admitted on the afternoon before the study protocol began.
Pre-assignment Details An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.
Arm/Group Title Healthy Volunteer
Hide Arm/Group Description

Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)

Intralipid

ClinOleic

Dextrose

Saline (control)

Period Title: 0 Hour (Baseline) of Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 24 Hours Into Saline Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 24 Hours Into Intralipid Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of ClinOleic Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into ClinOleic Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 24 Hours Into ClinOleic Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 0 Hour (Baseline) of Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 4 Hours Into Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Period Title: 24 Hours Into Dextrose Infusion
Started 12
Completed 12
Not Completed 0
Arm/Group Title Healthy Volunteer
Hide Arm/Group Description

Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)

Intralipid

ClinOleic

Dextrose

Saline (control)

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
41  (7)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
1.Primary Outcome
Title Flow Mediated Dilation
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid ClinOleic Dextrose Saline
Hide Arm/Group Description:
Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
Healthy subjects receive 24-hour infusion of normal saline (control)
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Error)
Unit of Measure: percentage of brachial artery diameter
10.3  (0.88) 8.9  (0.80) 9.2  (0.72) 9.1  (0.58)
2.Primary Outcome
Title Flow Mediated Dilation
Hide Description 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.
Time Frame 4 hours after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid ClinOleic Dextrose Saline
Hide Arm/Group Description:
Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
Healthy subjects receive 24-hour infusion of normal saline (control)
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Error)
Unit of Measure: percentage of brachial artery diameter
7.9  (0.83) 9.0  (0.88) 8.3  (0.67) 8.2  (1.37)
3.Primary Outcome
Title Flow Mediated Dilation
Hide Description 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.
Time Frame 24 hours after infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intralipid ClinOleic Dextrose Saline
Hide Arm/Group Description:
Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
Healthy subjects receive 24-hour infusion of normal saline (control)
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Error)
Unit of Measure: percentage of brachial artery diameter
7.2  (0.74) 9.1  (0.91) 10.2  (1.15) 9.7  (0.89)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Volunteer
Hide Arm/Group Description Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
All-Cause Mortality
Healthy Volunteer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Volunteer
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Volunteer
Affected / at Risk (%)
Total   0/12 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guillermo Umpierrez
Organization: Emory University
Phone: 404-778-1665
Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT02185729     History of Changes
Other Study ID Numbers: IRB00007543
First Submitted: July 7, 2014
First Posted: July 10, 2014
Results First Submitted: December 18, 2014
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014