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

University of Jena

Status: Completed

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: n-3 LC-PUFA

Study type: Interventional

Funder types: Other

Identifiers

NCT00639041

LSEP H26_06

[e-mail]

Details and patient eligibility

About

The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 43 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

n-3 LC-PUFA

Active Comparator group

Treatment:

Dietary Supplement: n-3 LC-PUFA