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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: n-3 PUFA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d | Dietary Supplement: n-3 PUFA<br>* products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder linseed oil (20g/d)(PPM, Magdeburg) echium oil (20g/d) (HARKE Nutrition) microalgae powder(12g/d)(HARKE Nutrition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG) |  | 10 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n-3 LC-PUFA, hypertriglyceridemic, human, TAG