Intervention With n3 LC-PUFA-supplemented Yogurt

Sponsor

University of Jena (Other)

Overall Status

Completed

CT.gov ID

NCT01244048

Collaborator

(none)

Enrollment

Location

1.9

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate Hypertriacylglycerolemic Subjects	Dietary Supplement: n3 long chain polyunsaturated fatty acids	N/A

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

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena		Germany	07743

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator: Gerhard Jahreis, Prof. Dr., Department of Nutrition, University Jena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gerhard Jahreis, Proffessor Dr. G. Jahreis, University of Jena

ClinicalTrials.gov Identifier:

NCT01244048

Other Study ID Numbers:

LSEP H35_08

First Posted:

Nov 19, 2010

Last Update Posted:

Mar 7, 2012

Last Verified:

Mar 1, 2012

Keywords provided by Gerhard Jahreis, Proffessor Dr. G. Jahreis, University of Jena

n3 LC-PUFA, yoghurt, inflammatory markers

Study Results

No Results Posted as of Mar 7, 2012