- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788917
Effects of Supplementation With Linseed Oil on Blood Lipids in Vegetarians
Effects of Supplementation With Linseed Oil on Blood Lipids and Fatty Acid Profile in Plasma and Erythrocyte Lipids in Vegetarians
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent studies suggest that the daily intake of n-3 LC-PUFA (EPA and DHA) can modulate cardiovascular risk factors and prevent lifestyle diseases.
The major dietary source of EPA and DHA is seafood (seaweeds and fatty cold water fishes), but they can also be found in lean red meat, in organ meats such as liver and brain. Vegetarians who do not eat meat or fish, have very low or negligible intakes of EPA (< 5 mg EPA/d) and DHA.
The purpose of the present study is to explore the tissue distribution and inter-conversion of ALA to n-3 LC-PUFA as consequence of linseed oil supplementation in vegetarians.
Eight vegetarians (3 m; 5 f) who do not eat meat, fish or seaweeds such as algae foods since least two years ago and two subjects (1 m; 1w) who consume the normal western style diet living in Jena (Germany) entered the study. The participants consumed 10 mL linseed oil per day for 10 weeks. The resulting daily dose of ALA was approx. 5.7 g/d.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- for the vegetarian sub-group : vegetarian diet pattern
Exclusion Criteria:
- high performance sport, daily alcohol intake and the in-take of dietary supplements (e.g., fish oil capsules)
- for the vegetarian sub-group, the consumption of fish and algae products (e.g. seaweeds, sushi)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vegetarians
Dietary supplement: 10 mL linseed oil per day
|
Dietary supplement: 10 mL linseed oil per day
|
Placebo Comparator: Omnivores
Dietary supplement: 10 mL linseed oil per day
|
Dietary supplement: 10 mL linseed oil per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EPA concentrations in plasma lipids and red blood cell lipids
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood lipids
Time Frame: 10 weeks
|
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol, lipoprotein a
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
parameters of iron status
Time Frame: 10 weeks
|
transferrin, ferritin, transferrin saturation, total ferritin
|
10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H39_09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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