Inter-conversion n-3 PUFA, VegetariansNCT01788917
Effects of Supplementation With Linseed Oil on Blood Lipids in Vegetarians
A study testing Linseed oil in people with Inter-conversion n-3 PUFA, Vegetarians, run by University of Jena.
Trial summary
The study was performed to investigate the effects of a daily consumption of linseed oil on fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Inter-conversion n-3 PUFA, Vegetarians
- What is being tested?
- Linseed oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- for the vegetarian sub-group : vegetarian diet pattern
Who cannot join
- 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)
About this study
Official title: Effects of Supplementation With Linseed Oil on Blood Lipids and Fatty Acid Profile in Plasma and Erythrocyte Lipids in Vegetarians
The study was performed to investigate the effects of a daily consumption of linseed oil on fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.
Read the 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.
- Conditions
- Inter-conversion n-3 PUFA, Vegetarians
- Being tested
- Linseed oil
- Keywords
- n-3 LC-PUFA, vegetarians, fatty acids, blood lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linseed oilDietary supplement
Dietary supplement: 10 mL linseed oil per day
| Study group | Role | What they receive |
|---|---|---|
| Vegetarians | Experimental | Dietary supplement: 10 mL linseed oil per day Receives: Dietary Supplement: Linseed oil |
| Omnivores | Placebo comparator | Dietary supplement: 10 mL linseed oil per day Receives: Dietary Supplement: Linseed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPA concentrations in plasma lipids and red blood cell lipids
Measured: 10 weeks
Secondary outcomes (1)
blood lipids
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol, lipoprotein a
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inter-conversion n-3 PUFA, VegetariansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788917
- Sponsor's protocol ID
- H39_09
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With Linseed Oil on Blood Lipids and Fatty Acid Profile in Plasma and Erythrocyte Lipids in Vegetarians
- ClinicalTrials.gov ID
- NCT01788917
- Acronym / sponsor ID
- H39_09
- Conditions
- Inter-conversion n-3 PUFA, Vegetarians
- Keywords
- n-3 LC-PUFA, vegetarians, fatty acids, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was performed to investigate the effects of a daily consumption of linseed oil on fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetarians | Experimental | Dietary Supplement: Linseed oilDietary supplement: 10 mL linseed oil per day |
| Omnivores | Placebo comparator | Dietary Supplement: Linseed oilDietary supplement: 10 mL linseed oil per day |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- for the vegetarian sub-group : vegetarian diet pattern
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linseed oilDietary supplement: 10 mL linseed oil per day | Dietary supplement | Omnivores, Vegetarians |
Primary outcome
EPA concentrations in plasma lipids and red blood cell lipids
Time frame: 10 weeks
1 secondary outcome
blood lipids
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Linseed oil in people with Inter-conversion n-3 PUFA, Vegetarians, run by University of Jena.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPA concentrations in plasma lipids and red blood cell lipids (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.