Intervention With n3 LC-PUFA-supplemented Yogurt: Effects on Cardiovascular Risk Factors and Inflammatory Biomarkers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
Investigators
Gerhard Jahreis
Proffessor Dr. G. Jahreis
University of Jena