Intervention With n3 LC-PUFA-supplemented Yogurt

Not Applicable

Completed

• Conditions: Moderate Hypertriacylglycerolemic Subjects

• Registration Number: NCT01244048
• Lead Sponsor: University of Jena

Brief Summary

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.

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 Timeline

• Study Start: 2009-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)	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

Name	Time	Method
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	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

Trial Locations

Locations (1)

University of Jena, Institute of Nutrition, Department of Nutritional Physiology; 🇩🇪 Jena, Germany