Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
NCT ID: NCT00639041
Last Updated: 2011-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2006-04-30
2007-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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placebo
Placebo
dairy products without special oils
n-3 LC-PUFA
n-3 LC-PUFA
n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
Interventions
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n-3 LC-PUFA
n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
Placebo
dairy products without special oils
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
43 Years
69 Years
ALL
No
Sponsors
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University of Jena
OTHER
Principal Investigators
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Gerhard Jahreis, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Jena, Dept. of Nutritional Physiology
Locations
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Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany
Countries
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References
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Dawczynski C, Martin L, Wagner A, Jahreis G. n-3 LC-PUFA-enriched dairy products are able to reduce cardiovascular risk factors: a double-blind, cross-over study. Clin Nutr. 2010 Oct;29(5):592-9. doi: 10.1016/j.clnu.2010.02.008. Epub 2010 Mar 20.
Other Identifiers
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LSEP H26_06
Identifier Type: -
Identifier Source: org_study_id