Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
n-3 PUFA
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring n-3 LC-PUFA, hypertriglyceridemic, human, TAG
Eligibility Criteria
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
Sites / Locations
- Friedrich Schiller University, Institute of Nutrition
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
placebo
Arm Description
products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d
Outcomes
Primary Outcome Measures
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
Secondary Outcome Measures
blood pressure
high sensitive C-reactive protein
oxidised LDL
lipoprotein a
Lipoprotein(a)
vascular cell adhesion molecule
vascular cell adhesion molecule
intracellular adhesion molecule
intracellular cell adhesion molecule
fatty acid distribution in plasma lipids and erythrocyte membranes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01437930
Brief Title
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
Official Title
Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
n-3 LC-PUFA, hypertriglyceridemic, human, TAG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
products (sausage, bread rolls, milk beverage, wafers) enriched with 20g sunflower oil/d
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 PUFA
Intervention Description
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)
Primary Outcome Measure Information:
Title
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
10 weeks
Title
high sensitive C-reactive protein
Time Frame
10 weeks
Title
oxidised LDL
Time Frame
10 weeks
Title
lipoprotein a
Description
Lipoprotein(a)
Time Frame
10 weeks
Title
vascular cell adhesion molecule
Description
vascular cell adhesion molecule
Time Frame
10 weeks
Title
intracellular adhesion molecule
Description
intracellular cell adhesion molecule
Time Frame
10 weeks
Title
fatty acid distribution in plasma lipids and erythrocyte membranes
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Friedrich Schiller University, Institute of Nutrition
City
Jena
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25216712
Citation
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.
Results Reference
derived
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Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
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