Diseases, MetabolicPhase 2/3TPN1NCT02185729

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

A Phase 2/3 study testing Intralipid, ClinOleic and Dextrose in people with Diseases, Metabolic and Insulin Sensitivity, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diseases, Metabolic, Insulin Sensitivity
What is being tested?: Intralipid, ClinOleic and Dextrose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Mar 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Grady Memorial Hospital
Atlanta, Georgia, 30303

Other trials in United States

About this study

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

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
Being tested: Intralipid, ClinOleic, Dextrose, Saline (control)
Keywords: Intravenous Feeding, Lipid Emulsions, Intravenous
Medical subject headings: Metabolic Diseases, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IntralipidDrug
Infusion of Intralipid (soybean-derived fat)
ClinOleicDrug
Infusion of ClinOleic (olive oil-based)
DextroseDrug
Infusion of dextrose (sugar) without fat
Saline (control)Other
Infusion of 0.9% normal saline

Study groups in NCT02185729
Study group	Role	What they receive
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) Receives: Drug: Intralipid; Drug: ClinOleic; Drug: Dextrose; Other: Saline (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 24 hours after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Mar 2012

First posted10 Jul 2014 (estimated)
Study startJun 2008
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diseases, MetabolicStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02185729
Sponsor's protocol ID: IRB00007543
Acronym: TPN1
Status last verified: Dec 2014
First submitted: 7 Jul 2014
Last updated: 31 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21832112

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02185729
Acronym / sponsor ID: TPN1 / IRB00007543
Conditions: Diseases, Metabolic, Insulin Sensitivity
Keywords: Intravenous Feeding, Lipid Emulsions, Intravenous
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Baxter Healthcare Corporation
Study start: Jun 2008
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 31 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy Volunteer	Active comparator	Drug: Intralipid, Drug: ClinOleic, Drug: Dextrose, Other: Saline (control)Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IntralipidInfusion of Intralipid (soybean-derived fat)	Drug	Healthy Volunteer
ClinOleicInfusion of ClinOleic (olive oil-based)	Drug	Healthy Volunteer
DextroseInfusion of dextrose (sugar) without fat	Drug	Healthy Volunteer
Saline (control)Infusion of 0.9% normal saline	Other	Healthy Volunteer

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 31 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteer	12	12

Primary outcome: Flow Mediated Dilation

Time frame: Baseline. Mean (Standard Error). Unit: percentage of brachial artery diameter

Measure	Intralipid n = 12	ClinOleic n = 12	Dextrose n = 12	Saline n = 12
Value	10.3 (0.88)	8.9 (0.80)	9.2 (0.72)	9.1 (0.58)

Primary outcome: Flow Mediated Dilation

Time frame: 4 hours after infusion. Mean (Standard Error). Unit: percentage of brachial artery diameter

Measure	Intralipid n = 12	ClinOleic n = 12	Dextrose n = 12	Saline n = 12
Value	7.9 (0.83)	9.0 (0.88)	8.3 (0.67)	8.2 (1.37)

Primary outcome: Flow Mediated Dilation

Time frame: 24 hours after infusion. Mean (Standard Error). Unit: percentage of brachial artery diameter

Measure	Intralipid n = 12	ClinOleic n = 12	Dextrose n = 12	Saline n = 12
Value	7.2 (0.74)	9.1 (0.91)	10.2 (1.15)	9.7 (0.89)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteer	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21832112Siqueira 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guillermo Umpierrez, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Intralipid, ClinOleic and Dextrose in people with Diseases, Metabolic and Insulin Sensitivity, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow Mediated Dilation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02185729, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.