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Intervention With n3 LC-PUFA-supplemented Yogurt

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244048
First Posted: November 19, 2010
Last Update Posted: March 7, 2012
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.
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
  Purpose
The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the modulation of cardiovascular risk factors and inflammatory biomarkers were determined.

Condition Intervention
Moderate Hypertriacylglycerolemic Subjects Dietary Supplement: n3 long chain polyunsaturated fatty acids

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention With n3 LC-PUFA-supplemented Yogurt: Effects on Cardiovascular Risk Factors and Inflammatory Biomarkers

Further study details as provided by Gerhard Jahreis, University of Jena:

Primary Outcome Measures:
  • Blood lipids (total cholesterol, HDL, LDL, triacylglycerols) [ Time Frame: change from baseline after 10 weeks ]

    change from baseline after 10 weeks

    Group 1: placebo Group 2: 0.8 g n3 LC-PUFA/125 g yoghurt per day Group 3: 3 g n3 LC-PUFA/200 g yoghurt per day



Secondary Outcome Measures:
  • fatty acid distribution in plasma lipids and erythrocyte membranes, eicosanoids in plasma, production of ex vivo stimulated cytokines by T cells, SNPs on CD36 genotype [ Time Frame: change from baseline after 10 weeks ]

    change from baseline after 10 weeks

    Group 1: placebo Group 2: 0.8 g n3 LC-PUFA/125 g yoghurt per day Group 3: 3 g n3 LC-PUFA/200 g yoghurt per day



Enrollment: 53
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: n3 long chain polyunsaturated fatty acids
    Group 1 (placebo) Group 2 (0.8 g n3 LC-PUFA/d in 125 g yoghurt) Group 3 (3 g n3 LC-PUFA/d in 200 g yoghurt)
Detailed Description:

Fifty three mildly hypertriacylglycerolemic subjects (TAG ≥ 150 mg/dL (1.7 mmol/L)) participated on the placebo-controlled, double-blind, parallel designed study.

The subjects consumed placebo yoghurt (1), or n3 LC-PUFA-enriched yoghurt (0.8 g n3 LC-PUFA/d (2), 3 g n3 LC-PUFA/d (3)) for 10 weeks.

Blood samples were taken at the beginning and at the end of the period.

Parameters:

  • Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
  • Fatty acid distribution of plasma lipids (PL) and erythrocyte membranes (EM)
  • Concentrations of eicosanoids (PGs, HETEs)
  • Production of ex vivo stimulated cytokines by T cells
  • SNPs in the CD36 genotype
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypertriacylglycerolemic subjects (TAG: ≥ 150 mg/dl (1.7 mmol/l))

Exclusion Criteria:

  • patients receiving blood-diluting and lipid-lowering medications or glucocorticoids
  • patients suffering from gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyper- and hypothyroidism) and hypercholesteremic patients with familial previous impacts
  • patients taking dietary supplements (e.g., fish oil capsules, vitamin E) or having either known allergies or foodstuff indigestibility
  • further exclusion criteria: smoking, high sportive activity or daily alcohol intake
  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): NCT01244048


Locations
Germany
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Department of Nutrition, University Jena
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Jahreis, Proffessor Dr. G. Jahreis, University of Jena
ClinicalTrials.gov Identifier: NCT01244048     History of Changes
Other Study ID Numbers: LSEP H35_08
First Submitted: November 16, 2010
First Posted: November 19, 2010
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Gerhard Jahreis, University of Jena:
n3 LC-PUFA, yoghurt, inflammatory markers