Clinical trial NCT00639041: Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: n-3 LC-PUFA
hypertriglyceridemic
human
TAG
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 51
Sex: ALL
Minimum age (years): 43
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)
timeFrame: 15 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: 15 weeks
measure: fibrinogen
timeFrame: 15 weeks
measure: homocysteine
timeFrame: 15 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: University of Jena, Dept. of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawczynski C, Martin L, Wagner A, Jahreis G. n-3 LC-PUFA-enriched dairy products are able to reduce cardiovascular risk factors: a double-blind, cross-over study. Clin Nutr. 2010 Oct;29(5):592-9. doi: 10.1016/j.clnu.2010.02.008. Epub 2010 Mar 20.