Intervention With n3 LC-PUFA-supplemented Yogurt

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Moderate Hypertriacylglycerolemic Subjects

Intervention / Treatment
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* Dietary Supplement: n3 long chain polyunsaturated fatty acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids (total cholesterol, HDL, LDL, triacylglycerols) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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n3 LC-PUFA, yoghurt, inflammatory markers