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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01437930
Enrollment
60
Registered
2011-09-21
Start date
2011-09-30
Completion date
2012-04-30
Last updated
2014-07-29

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

Conditions

Hypertriglyceridemia

Keywords

n-3 LC-PUFA, hypertriglyceridemic, human, TAG

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.

Interventions

DIETARY_SUPPLEMENTn-3 PUFA

products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder 1. linseed oil (20g/d)(PPM, Magdeburg) 2. echium oil (20g/d) (HARKE Nutrition) 3. microalgae powder(12g/d)(HARKE Nutrition)

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)10 weeks

Secondary

MeasureTime frameDescription
high sensitive C-reactive protein10 weeks
oxidised LDL10 weeks
lipoprotein a10 weeksLipoprotein(a)
blood pressure10 weeks
intracellular adhesion molecule10 weeksintracellular cell adhesion molecule
fatty acid distribution in plasma lipids and erythrocyte membranes10 weeks
vascular cell adhesion molecule10 weeksvascular cell adhesion molecule

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026