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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01437930
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertriglyceridemia Dietary Supplement: n-3 PUFA

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2011
Primary Completion Date : February 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437930


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Jahreis, Proffessor, University of Jena
ClinicalTrials.gov Identifier: NCT01437930     History of Changes
Other Study ID Numbers: H51_11
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: March 2012

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

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