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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02185729
• Collaborator: Baxter Healthcare Corporation (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• 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: Jun 1, 2008
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Flow Mediated Dilation [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303

Sponsors and Collaborators

• Emory University
• Baxter Healthcare Corporation

Investigators

• Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Umpierrez, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02185729
• Other Study ID Numbers: IRB00007543
• First Posted: Jul 10, 2014
• Last Update Posted: Dec 31, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Guillermo Umpierrez, Professor, Emory University: Intravenous Feeding; Lipid Emulsions, Intravenous
• Additional relevant MeSH terms: Insulin Resistance; Metabolic Diseases; Hypersensitivity; Soybean oil, phospholipid emulsion

Study Results

Participant Flow

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 Detail	An overnight fast, subjects underwent research studies in the morning with the infusion starting between 1200 and 1300 h.

Arm/Group Title	Healthy Volunteer
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: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0
Period Title: 0 Hour (Baseline) of Saline Infusion
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Healthy Volunteer
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 Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (7)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%

Outcome Measures

1. Primary Outcome

Title	Flow Mediated Dilation
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralipid	ClinOleic	Dextrose	Saline
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)
Measure Participants	12	12	12	12
Mean (Standard Error) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralipid	ClinOleic	Dextrose	Saline
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)
Measure Participants	12	12	12	12
Mean (Standard Error) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralipid	ClinOleic	Dextrose	Saline
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)
Measure Participants	12	12	12	12
Mean (Standard Error) [percentage of brachial artery diameter]	7.2 (0.74)	9.1 (0.91)	10.2 (1.15)	9.7 (0.89)

Adverse Events

Arm/Group Title	Healthy Volunteer
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Healthy Volunteer
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Volunteer
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/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.

More Information

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.