Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 19, 2011
CompletedFirst Posted
Study publicly available on registry
September 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJuly 29, 2014
March 1, 2012
5 months
September 19, 2011
July 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
10 weeks
Secondary Outcomes (7)
blood pressure
10 weeks
high sensitive C-reactive protein
10 weeks
oxidised LDL
10 weeks
lipoprotein a
10 weeks
vascular cell adhesion molecule
10 weeks
- +2 more secondary outcomes
Study Arms (1)
placebo
PLACEBO COMPARATORproducts (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d
Interventions
products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder 1. linseed oil (20g/d)(PPM, Magdeburg) 2. echium oil (20g/d) (HARKE Nutrition) 3. microalgae powder(12g/d)(HARKE Nutrition)
Eligibility Criteria
You may qualify if:
- TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friedrich Schiller University, Institute of Nutrition
Jena, 07743, Germany
Related Publications (1)
Dittrich M, Jahreis G, Bothor K, Drechsel C, Kiehntopf M, Bluher M, Dawczynski C. Benefits of foods supplemented with vegetable oils rich in alpha-linolenic, stearidonic or docosahexaenoic acid in hypertriglyceridemic subjects: a double-blind, randomized, controlled trail. Eur J Nutr. 2015 Sep;54(6):881-93. doi: 10.1007/s00394-014-0764-2. Epub 2014 Sep 13.
PMID: 25216712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Proffessor
Study Record Dates
First Submitted
September 19, 2011
First Posted
September 21, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
July 29, 2014
Record last verified: 2012-03