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

Emory University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diseases, Metabolic; Insulin Sensitivity

Treatments: Drug: ClinOleic; Drug: Intralipid; Other: Saline (control); Drug: Dextrose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02185729

IRB00007543

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Healthy Volunteer

Active Comparator group

Description:

Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)

Treatment:

Drug: Dextrose

Drug: Intralipid

Drug: ClinOleic

Other: Saline (control)