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Intervention With n3 LC-PUFA-supplemented Yogurt

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01244048
First received: November 16, 2010
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Jena:

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

    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 ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 16, 2010
Last Updated: March 6, 2012
Health Authority: Germany: Ethical Committee of the Friedrich Schiller University, Jena

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

ClinicalTrials.gov processed this record on May 22, 2013