Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02185729 | Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers | PHASE2 | COMPLETED | 12 | — | — | Jun 1, 2008 | Mar 1, 2012 | Dec 31, 2014 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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) |
| Name | Type | Description |
|---|---|---|
| Intralipid | DRUG | Infusion of Intralipid (soybean-derived fat) |
| ClinOleic | DRUG | Infusion of ClinOleic (olive oil-based) |
| Dextrose | DRUG | Infusion of dextrose (sugar) without fat |
| Saline (control) | OTHER | Infusion of 0.9% normal saline |
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 \> up...