Hypertriglyceridemia Clinical Trial
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
The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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