Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
n-3 LC-PUFA
Placebo
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:
- blood diluted medications
- 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
- Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
n-3 LC-PUFA
Arm Description
Outcomes
Primary Outcome Measures
blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)
Secondary Outcome Measures
blood pressure
fibrinogen
homocysteine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00639041
Brief Title
Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
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 n-3 LC-PUFA supplemented dairy products 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. 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 triacylglyceride (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 eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha linolenic acid (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.
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
n-3 LC-PUFA
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 LC-PUFA
Intervention Description
n-3 LC-PUFA supplemented dairy products (yoghurt, cheese, butter): 3.3 g n-3 FA/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
dairy products without special oils
Primary Outcome Measure Information:
Title
blood lipids (total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), TAG)
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Time Frame
15 weeks
Title
fibrinogen
Time Frame
15 weeks
Title
homocysteine
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
43 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
Exclusion Criteria:
blood diluted medications
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
University of Jena, Dept. of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20304540
Citation
Dawczynski C, Martin L, Wagner A, Jahreis G. n-3 LC-PUFA-enriched dairy products are able to reduce cardiovascular risk factors: a double-blind, cross-over study. Clin Nutr. 2010 Oct;29(5):592-9. doi: 10.1016/j.clnu.2010.02.008. Epub 2010 Mar 20.
Results Reference
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Changes in Blood Lipids After Long-term Consumption of n-3 LC-PUFA-Enriched Dairy Products
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