Effect of Omega-3 Fatty Acids (n3-PUFA, Zodin®) on Post-Prandial Triglyceride Tolerance - Zodin and OTT

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010207-83-DE

Enrollment

Registered

2009-03-19

Start date

2009-06-08

Completion date

Unknown

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Zodin Product Name: Zodin Pharmaceutical Form: Capsule, soft INN or Proposed INN: Omega-3-Säurenethylester 90 Current Sponsor code: n3PUFA2009 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: ?- 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 ( 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026