Trial Outcomes & Findings for Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers (NCT NCT02185729)

Last Updated: 2014-12-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Baseline

Results posted on

2014-12-31

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Healthy Volunteer 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)
0 Hour (Baseline) of Saline Infusion STARTED	12
0 Hour (Baseline) of Saline Infusion COMPLETED	12
0 Hour (Baseline) of Saline Infusion NOT COMPLETED	0
4 Hours Into Saline Infusion STARTED	12
4 Hours Into Saline Infusion COMPLETED	12
4 Hours Into Saline Infusion NOT COMPLETED	0
24 Hours Into Saline Infusion STARTED	12
24 Hours Into Saline Infusion COMPLETED	12
24 Hours Into Saline Infusion NOT COMPLETED	0
0 Hour (Baseline) of Intralipid Infusion STARTED	12
0 Hour (Baseline) of Intralipid Infusion COMPLETED	12
0 Hour (Baseline) of Intralipid Infusion NOT COMPLETED	0
4 Hours Into Intralipid Infusion STARTED	12
4 Hours Into Intralipid Infusion COMPLETED	12
4 Hours Into Intralipid Infusion NOT COMPLETED	0
24 Hours Into Intralipid Infusion STARTED	12
24 Hours Into Intralipid Infusion COMPLETED	12
24 Hours Into Intralipid Infusion NOT COMPLETED	0
0 Hour (Baseline) of ClinOleic Infusion STARTED	12
0 Hour (Baseline) of ClinOleic Infusion COMPLETED	12
0 Hour (Baseline) of ClinOleic Infusion NOT COMPLETED	0
4 Hours Into ClinOleic Infusion STARTED	12
4 Hours Into ClinOleic Infusion COMPLETED	12
4 Hours Into ClinOleic Infusion NOT COMPLETED	0
24 Hours Into ClinOleic Infusion STARTED	12
24 Hours Into ClinOleic Infusion COMPLETED	12
24 Hours Into ClinOleic Infusion NOT COMPLETED	0
0 Hour (Baseline) of Dextrose Infusion STARTED	12
0 Hour (Baseline) of Dextrose Infusion COMPLETED	12
0 Hour (Baseline) of Dextrose Infusion NOT COMPLETED	0
4 Hours Into Dextrose Infusion STARTED	12
4 Hours Into Dextrose Infusion COMPLETED	12
4 Hours Into Dextrose Infusion NOT COMPLETED	0
24 Hours Into Dextrose Infusion STARTED	12
24 Hours Into Dextrose Infusion COMPLETED	12
24 Hours Into Dextrose Infusion NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteer n=12 Participants 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)
Age, Continuous	41 years STANDARD_DEVIATION 7 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Intralipid n=12 Participants Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)	ClinOleic n=12 Participants Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)	Dextrose n=12 Participants Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat	Saline n=12 Participants Healthy subjects receive 24-hour infusion of normal saline (control)
Flow Mediated Dilation	10.3 percentage of brachial artery diameter Standard Error 0.88	8.9 percentage of brachial artery diameter Standard Error 0.80	9.2 percentage of brachial artery diameter Standard Error 0.72	9.1 percentage of brachial artery diameter Standard Error 0.58

PRIMARY outcome

Timeframe: 4 hours after infusion

Outcome measures

Outcome measures
Measure	Intralipid n=12 Participants Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)	ClinOleic n=12 Participants Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)	Dextrose n=12 Participants Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat	Saline n=12 Participants Healthy subjects receive 24-hour infusion of normal saline (control)
Flow Mediated Dilation	7.9 percentage of brachial artery diameter Standard Error 0.83	9.0 percentage of brachial artery diameter Standard Error 0.88	8.3 percentage of brachial artery diameter Standard Error 0.67	8.2 percentage of brachial artery diameter Standard Error 1.37

PRIMARY outcome

Timeframe: 24 hours after infusion

Outcome measures

Outcome measures
Measure	Intralipid n=12 Participants Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)	ClinOleic n=12 Participants Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)	Dextrose n=12 Participants Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat	Saline n=12 Participants Healthy subjects receive 24-hour infusion of normal saline (control)
Flow Mediated Dilation	7.2 percentage of brachial artery diameter Standard Error 0.74	9.1 percentage of brachial artery diameter Standard Error 0.91	10.2 percentage of brachial artery diameter Standard Error 1.15	9.7 percentage of brachial artery diameter Standard Error 0.89

Adverse Events

Healthy Volunteer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place