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

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ClinicalTrials.gov Identifier: NCT00639041
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : September 22, 2011
Sponsor:
Information provided by:
University of Jena

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dietary Supplement: n-3 LC-PUFA Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

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



Primary Outcome Measures :
  1. blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG) [ Time Frame: 15 weeks ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 15 weeks ]
  2. fibrinogen [ Time Frame: 15 weeks ]
  3. homocysteine [ Time Frame: 15 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   43 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00639041     History of Changes
Other Study ID Numbers: LSEP H26_06
Gerhard.Jahreis@uni-jena.de
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: February 2008

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