Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors|
- blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- blood pressure [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- high sensitive C-reactive protein [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- oxidised LDL [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- lipoprotein a [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]Lipoprotein(a)
- vascular cell adhesion molecule [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]vascular cell adhesion molecule
- intracellular adhesion molecule [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]intracellular cell adhesion molecule
- fatty acid distribution in plasma lipids and erythrocyte membranes [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d
Dietary Supplement: n-3 PUFA
products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437930
|Friedrich Schiller University, Institute of Nutrition|
|Jena, Germany, 07743|