Phase 3
N=12
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Diseases, Metabolic · Insulin Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT02185729 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Flow Mediated Dilation — 10.3; 8.9; 9.2; 9.1 percentage of brachial artery diameter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intralipid (Drug); ClinOleic (Drug); Dextrose (Drug); Saline (control) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow Mediated Dilation |
7.2; 9.1; 10.2; 9.7 | — |
| PRIMARY Flow Mediated Dilation |
7.2; 9.1; 10.2; 9.7 | — |
| PRIMARY Flow Mediated Dilation |
7.2; 9.1; 10.2; 9.7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02185729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.