Intervention With n3 LC-PUFA-supplemented Yogurt

March 6, 2012 updated by: Gerhard Jahreis, University of Jena

Intervention With n3 LC-PUFA-supplemented Yogurt: Effects on Cardiovascular Risk Factors and Inflammatory Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Jena, Germany, 07743
        • University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline after 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline after 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., Department of Nutrition, University Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LSEP H35_08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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