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Completed

NCT Number: NCT01437930

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University, Institute of Nutrition

Jena, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 PUFA

Dietary Supplement

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)

Primary outcomes

  1. blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)

    Time frame: 10 weeks

Secondary outcomes

  1. blood pressure

    Time frame: 10 weeks

  2. high sensitive C-reactive protein

    Time frame: 10 weeks

  3. oxidised LDL

    Time frame: 10 weeks

  4. lipoprotein a

    Time frame: 10 weeks

    Lipoprotein(a)

  5. vascular cell adhesion molecule

    Time frame: 10 weeks

    vascular cell adhesion molecule

  6. intracellular adhesion molecule

    Time frame: 10 weeks

    intracellular cell adhesion molecule

  7. fatty acid distribution in plasma lipids and erythrocyte membranes

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2011
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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