Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products

Study Overview
=================
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.

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

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Dietary Supplement: n-3 LC-PUFA
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 43 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Dietary Supplement: Placebo<br>* dairy products without special oils<br>|
| Active Comparator: n-3 LC-PUFA<br> | Dietary Supplement: n-3 LC-PUFA<br>* n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG) |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 15 weeks | 
| fibrinogen |  | 15 weeks | 
| homocysteine |  | 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-3 LC-PUFA, hypertriglyceridemic, human, TAG