Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients

Hypertriglyceridemia Clinical Trial

Official title:

Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437930
• Other study ID #: H51_11
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: July 28, 2014
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2012
• 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 a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on 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. Written 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. Sixty hypertriglyceridemic patients (with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.

The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 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 10 weeks. Patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were enriched with sunflower oil (20g/d).

In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid (DHA).

Venous blood is collected at the beginning and at the end of each period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• TAG values = 150 mg/dl or = 1.7 mmol/L

Exclusion Criteria:

• 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, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• n-3 PUFA
products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder linseed oil (20g/d)(PPM, Magdeburg) echium oil (20g/d) (HARKE Nutrition) microalgae powder(12g/d)(HARKE Nutrition)

Locations

Country	Name	City	State
Germany	Friedrich Schiller University, Institute of Nutrition	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)		10 weeks	Yes
Secondary	blood pressure		10 weeks	Yes
Secondary	high sensitive C-reactive protein		10 weeks	Yes
Secondary	oxidised LDL		10 weeks	Yes
Secondary	lipoprotein a	Lipoprotein(a)	10 weeks	Yes
Secondary	vascular cell adhesion molecule	vascular cell adhesion molecule	10 weeks	Yes
Secondary	intracellular adhesion molecule	intracellular cell adhesion molecule	10 weeks	Yes
Secondary	fatty acid distribution in plasma lipids and erythrocyte membranes		10 weeks	Yes