Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products

September 21, 2011 updated by: University of Jena

Changes in Blood Lipids After Long Time Consumption of n-3 LC-PUFA-enriched Dairy Products in Hypertriglyceridemic Patients: a Randomized, Double-blind, Cross-over Study

The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.

As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Fifty-one hypertriglyceridemic patients (25 f, 26 m; with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) entered the study.

The placebo-controlled, randomized double-blind cross-over study consisted of two investigation periods of 15 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 15 weeks. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially exchanged by special oils (fish oil, rapeseed oil) with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (ALA). The daily dose of n-3 FA amounted to 3.3 g, consisting of 1.5 g EPA, 1.2 g DHA, 0.2 g DPA, and 0.2 g ALA.

Venous blood and 24h urine were collected at the beginning and at the end of each period.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L

Exclusion Criteria:

  • blood diluted medications
  • lipid lowering medications
  • glucocorticoids
  • gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
  • daily alcohol abuse
  • taking dietary supplements (e. g., fish oil capsules, vitamin E)
  • known allergies or foodstuff indigestibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: Placebo
dairy products without special oils
Active Comparator: n-3 LC-PUFA
Dietary supplement: n-3 LC-PUFA
n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)
Time Frame: 15 weeks
15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: 15 weeks
15 weeks
fibrinogen
Time Frame: 15 weeks
15 weeks
homocysteine
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., University of Jena, Dept. of Nutritional Physiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP H26_06
  • Gerhard.Jahreis@uni-jena.de

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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