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Sponsored by: |
University of Jena |
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Information provided by: | University of Jena |
ClinicalTrials.gov Identifier: | NCT00639041 |
The study was performed to investigate the effects of n-3 LC-PUFA supplemented dairy products cardiovascular risk factors in hypertriglyceridemic patients.
Condition | Intervention |
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Hypertriglyceridemia |
Dietary Supplement: n-3 LC-PUFA |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Enrollment: | 51 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
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 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 EPA, DHA, and 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.
Ages Eligible for Study: | 43 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Thuringia | |
Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology | |
Jena, Thuringia, Germany, 07743 |
Principal Investigator: | Gerhard Jahreis, Prof. Dr. | University of Jena, Dept. of Nutritional Physiology |
Study ID Numbers: | LSEP H26_06, Gerhard.Jahreis@uni-jena.de |
Study First Received: | March 12, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00639041 |
Health Authority: | Germany: Ethics Commission |
n-3 LC-PUFA hypertriglyceridemic human TAG |
Metabolic Diseases Hyperlipidemias Hypertriglyceridemia |
Metabolic disorder Dyslipidemias Lipid Metabolism Disorders |