Skip to main content
OpenTrials
Completed

NCT Number: NCT01244048

Intervention With n3 LC-PUFA-supplemented Yogurt

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, 07743, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n3 long chain polyunsaturated fatty acids

Dietary Supplement

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)

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 19, 2010
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.