Hypertriglyceridemia Clinical Trial
Official title:
Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
Verified date | March 2012 |
Source | University of Jena |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Friedrich Schiller University, Institute of Nutrition | Jena |
Lead Sponsor | Collaborator |
---|---|
University of Jena |
Germany,
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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