Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
- Conditions
- Hypertriglyceridemia
- Registration Number
- NCT00639041
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG) 15 weeks
- Secondary Outcome Measures
Name Time Method blood pressure 15 weeks fibrinogen 15 weeks homocysteine 15 weeks
Trial Locations
- Locations (1)
Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
🇩🇪Jena, Thuringia, Germany
Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology🇩🇪Jena, Thuringia, Germany