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Intervention With n3 LC-PUFA-supplemented Yogurt

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01244048
Enrollment
53
Registered
2010-11-19
Start date
2009-02-28
Completion date
2009-04-30
Last updated
2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Hypertriacylglycerolemic Subjects

Keywords

n3 LC-PUFA, yoghurt, inflammatory markers

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

Interventions

DIETARY_SUPPLEMENTn3 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)

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)change from baseline after 10 weekschange 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

MeasureTime frameDescription
fatty acid distribution in plasma lipids and erythrocyte membranes, eicosanoids in plasma, production of ex vivo stimulated cytokines by T cells, SNPs on CD36 genotypechange from baseline after 10 weekschange 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026