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Completed

NCT Number: NCT00639041

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

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

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Key information

Age range

43 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 LC-PUFA

Dietary Supplement

n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d

Placebo

Dietary Supplement

dairy products without special oils

Primary outcomes

  1. blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)

    Time frame: 15 weeks

Secondary outcomes

  1. blood pressure

    Time frame: 15 weeks

  2. fibrinogen

    Time frame: 15 weeks

  3. homocysteine

    Time frame: 15 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 19, 2008
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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