Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
|Hypertriglyceridemia||Dietary Supplement: n-3 LC-PUFA Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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|
- 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 ]
|Study Start Date:||April 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|