Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients

Not Applicable

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: n-3 PUFA

• Registration Number: NCT01437930
• Lead Sponsor: University of Jena

Brief Summary

The study was performed to investigate the effects of a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.

Detailed Description

Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.

As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Sixty hypertriglyceridemic patients (with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.

The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were enriched with sunflower oil (20g/d).

In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid (DHA).

Venous blood is collected at the beginning and at the end of each period.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Study Completion: 2012-04
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L

Exclusion Criteria

• Lipid lowering medications
• Glucocorticoids
• Gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
• Daily alcohol abuse
• Taking dietary supplements (e. g., fish oil capsules, vitamin E)
• Known allergies or foodstuff indigestibility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	n-3 PUFA	products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d

Primary Outcome Measures

Name	Time	Method
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)	10 weeks

Secondary Outcome Measures

Name	Time	Method
vascular cell adhesion molecule	10 weeks	vascular cell adhesion molecule
lipoprotein a	10 weeks	Lipoprotein(a)
blood pressure	10 weeks
high sensitive C-reactive protein	10 weeks
oxidised LDL	10 weeks
intracellular adhesion molecule	10 weeks	intracellular cell adhesion molecule
fatty acid distribution in plasma lipids and erythrocyte membranes	10 weeks

Trial Locations

Locations (1)

Friedrich Schiller University, Institute of Nutrition; 🇩🇪 Jena, Germany