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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01437930
First received: September 19, 2011
Last updated: November 30, 2012
Last verified: March 2012
History of Changes
  Purpose

The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.


Condition Intervention
Hypertriglyceridemia
 Dietary Supplement: n-3 PUFA

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  1. linseed oil (20g/d)(PPM, Magdeburg)
  2. echium oil (20g/d) (HARKE Nutrition)
  3. microalgae powder(12g/d)(HARKE Nutrition)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437930

Locations
Germany
Friedrich Schiller University, Institute of Nutrition
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Proffessor, University of Jena
ClinicalTrials.gov Identifier: NCT01437930     History of Changes
Other Study ID Numbers: H51_11
Study First Received: September 19, 2011
Last Updated: November 30, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
n-3 LC-PUFA
hypertriglyceridemic
human
TAG

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013