Effect of Omega-3 Fatty Acids (n3-PUFA, Zodin®) on Post-Prandial Triglyceride Tolerance - Zodin and OTT
- Conditions
- The proposed study investigates post-prandial hypertriglyceridemia, i.e. patients with a pathological increase in serum-triglyceride levels after intake of a fatty meal.
- Registration Number
- EUCTR2009-010207-83-DE
- Lead Sponsor
- ehrstuhl für Klinisch-Experimentelle Medizin, Universitaet des Saarlandes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
- stable coronary artery disease
- pathological triglyceride tolerance (defined as highest quintile in a a study we are currently performing on 500 patients to define triglyceride tolerance)
- age > 18
- written informed consent
- established medical therapy for coronary artery disease according to current guidelines, including statin, aspirin, and renin-angiotensin-inhibitor (ACE-I or ARB)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
?- intolerance to soy or peanuts
- anticoagulant therapy
- acute coronary syndrome
- hemodynamically relevant heart rhythm abnormalities
- high grade valve pathologies
- severe disease affecting well-being of patients, such as gastroinstestinal disease, acute infection, exsiccosis, pain, decompensated heart failure, recent (< 4 weeks) operation
?-severe liver or kidney malfunction (ALAT/ALAT > 2.5-fold upper limit of normal, glomerular filtration rate < 30 ml/min)
- intolerance to lipid test: acute and chronic pancreatitis, symptomatic cholecystitis, instestinal malabsoprtion
- intolerance to milk (products)
- problems swallowing and danger of aspiration
- pregnancy and lactation
- oncological disease
- inability to provide written informed consent
- psychiatric disorders including substance abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show if omega-3 fatty acids (Zodin(R)) can improve post-prandial triglyceride tolerance, defined as the increase in serum triglycerides 2h, 3h, and 5, after intake of a fatty meal.;Secondary Objective: n/a;Primary end point(s): Primary end point is the post-prandial triglyceride kinetic, determined by an oral triglyceride tolerance test (oTT), after three weeks of treatment. After blood is taken for a lipid profile (including serum triglycerides, cholesterol, LDL- and HDL-cholesterol), patients will consume 250 ml of cream. Serum-triglyceride rise will be monitored at 2, 3 and 5 hours. We expect the study medication (Zodin) to improve triglyceride tolerance.
- Secondary Outcome Measures
Name Time Method