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
|Condition or disease||Intervention/treatment||Phase|
|Hypertriglyceridemia||Dietary Supplement: n-3 LC-PUFA Dietary Supplement: Placebo||Not Applicable|
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|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|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
- blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG) [ Time Frame: 15 weeks ]
- blood pressure [ Time Frame: 15 weeks ]
- fibrinogen [ Time Frame: 15 weeks ]
- homocysteine [ Time Frame: 15 weeks ]
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
|Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology|
|Jena, Thuringia, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Prof. Dr.||University of Jena, Dept. of Nutritional Physiology|