Clinical trial NCT01437930: Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
Official title: Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: n-3 LC-PUFA
hypertriglyceridemic
human
TAG
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
timeFrame: 10 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: 10 weeks
measure: high sensitive C-reactive protein
timeFrame: 10 weeks
measure: oxidised LDL
timeFrame: 10 weeks
measure: lipoprotein a
timeFrame: 10 weeks
measure: vascular cell adhesion molecule
timeFrame: 10 weeks
measure: intracellular adhesion molecule
timeFrame: 10 weeks
measure: fatty acid distribution in plasma lipids and erythrocyte membranes
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University, Institute of Nutrition
Study officials:
References:
citation: Dittrich M, Jahreis G, Bothor K, Drechsel C, Kiehntopf M, Bluher M, Dawczynski C. Benefits of foods supplemented with vegetable oils rich in alpha-linolenic, stearidonic or docosahexaenoic acid in hypertriglyceridemic subjects: a double-blind, randomized, controlled trail. Eur J Nutr. 2015 Sep;54(6):881-93. doi: 10.1007/s00394-014-0764-2. Epub 2014 Sep 13.