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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00639041
Enrollment
51
Registered
2008-03-19
Start date
2006-04-30
Completion date
2007-05-31
Last updated
2011-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

n-3 LC-PUFA, hypertriglyceridemic, human, TAG

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.

Interventions

DIETARY_SUPPLEMENTn-3 LC-PUFA

n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d

DIETARY_SUPPLEMENTPlacebo

dairy products without special oils

Sponsors

University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
43 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)15 weeks

Secondary

MeasureTime frame
blood pressure15 weeks
fibrinogen15 weeks
homocysteine15 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026