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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00639041
First received: March 12, 2008
Last updated: September 21, 2011
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention
Hypertriglyceridemia
 Dietary Supplement: n-3 LC-PUFA
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG) [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood pressure [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
  • fibrinogen [ Time Frame: 15 weeks ]
  • homocysteine [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   43 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639041

Locations
Germany
Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. University of Jena, Dept. of Nutritional Physiology
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00639041     History of Changes
Other Study ID Numbers: LSEP H26_06, Gerhard.Jahreis@uni-jena.de
Study First Received: March 12, 2008
Last Updated: September 21, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
n-3 LC-PUFA
hypertriglyceridemic
human
TAG

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013