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Intervention With n3 LC-PUFA-supplemented Yogurt

U

University of Jena

Status

Completed

Conditions

Moderate Hypertriacylglycerolemic Subjects

Treatments

Dietary Supplement: n3 long chain polyunsaturated fatty acids

Study type

Interventional

Funder types

Other

Identifiers

NCT01244048
LSEP H35_08

Details and patient eligibility

About

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.

Full 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

Enrollment

53 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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