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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639041
• Other study ID #: LSEP H26_06
• Secondary ID: Gerhard.Jahreis@
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: September 21, 2011
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: February 2008
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 43 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• n-3 LC-PUFA
n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
• Placebo
dairy products without special oils

Locations

Country	Name	City	State
Germany	Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)		15 weeks	Yes
Secondary	blood pressure		15 weeks	Yes
Secondary	fibrinogen		15 weeks
Secondary	homocysteine		15 weeks	Yes