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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01437930
Other study ID # H51_11
Secondary ID
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


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
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