Lipid Metabolism DisordersNCT01365078
Stearidonic Acid and Lipid Metabolism
A study testing Echium oil (SDA-rich oil) and high-oleic acid sunflower oil (HOSO) (low in SDA) in people with Lipid Metabolism Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or C18:3n-3), but conversion is low. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Echium oil (SDA-rich oil) and high-oleic acid sunflower oil (HOSO) (low in SDA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Feb 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18-70 years
- Quetelet-index between 25-35 kg/m2
- mean serum triacylglycerol < 3.0 mmol/L
Who cannot join
- unstable body weight (weight gain or loss >2 kg in the past 3 months)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a diet known to affect serum lipid or glucose metabolism
- active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebrovascular accident)
- severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
- abuse of drugs
Show all 11Show fewer
- more than 21 alcohol consumptions per week for men and 14 consumptions for women
- not or difficult to venipuncture as evidenced during the screening visits
- use of an investigational product within the previous 30 days
- not willing to stop the consumption of vitamin supplements, fish oil capsules, fatty fish such as salmon, herring, mackerel and sardine or products rich in plant stanol or sterol esters 3 weeks before the start of the study
- not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
About this study
Official title: Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus, providing oils rich in SDA may increase the endogenous synthesis of EPA. This may subsequently lower serum triacylglycerol concentrations, an effect frequently observed after EPA supplementation, especially in people with increased triacylglycerol levels.
The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol concentrations in healthy overweight and slightly obese men and women. The minor objective is to study the effects of echium oil on the omega-3 index, which is negatively related to cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.
Read the detailed description
Using a randomized, double-blind, placebo controlled crossover design, subjects will receive in random order for six weeks with a washout period of at least 14 days, daily 10 g of echium oil or a high-oleic acid sunflower oil (HOSO) as control.
Thirty-six healthy men and women, aged 18-70 yrs, with a body mass index between 25 and 35 kg/m2 will participate. Subjects with an increased BMI are at increased risk to develop hypertriglyceridemia.
During the experimental period, subjects will receive daily one sachet at lunch and one sachet at dinner each providing 5 g of echium oil. During the control period, subjects will receive daily at the same time points sachets with the same amount of HOSO.
The main study parameter is the change in fasting serum triacylglycerol concentrations. The secondary endpoint is the change in the omega-3 index.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Echium oil (SDA-rich oil), high-oleic acid sunflower oil (HOSO) (low in SDA)
- Keywords
- n-3 polyunsaturated fatty acids, Stearidonic acid, Lipid metabolism, Serum triacylglycerol
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echium oil (SDA-rich oil)Dietary supplement
Also called Oil rich in Stearidonic acid
The echium oil will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the experimental period twice a day, i.e. one sachet at lunch and one sachet at dinner
high-oleic acid sunflower oil (HOSO) (low in SDA)Dietary supplement
Also called Oil low in Stearidonic acid
The HOSO will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the control period twice a day, i.e. one sachet at lunch and one sachet at dinner
| Study group | Role | What they receive |
|---|---|---|
| Echium oil (SDA-rich oil) | Experimental | Not described Receives: Dietary Supplement: Echium oil (SDA-rich oil) |
| High-oleic acid sunflower oil (HOSO) | Placebo comparator | low in SDA Receives: Dietary Supplement: high-oleic acid sunflower oil (HOSO) (low in SDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting serum triacylglycerol concentrations
Measured: Measured in week 1, 3,5 and 6 of the experimental and the control period
Secondary outcomes (1)
omega-3 index
The proportion of EPA and DHA in red blood cells
Measured: Measured in week 1, 3, 5 and 6 of the experimental and the control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bioriginal Europe / Asia B.V.
- Responsible party
- Sponsor
- Investigators
- Ronald P Mensink, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365078
- Sponsor's protocol ID
- MEC 11-3-029
- Status last verified
- Mar 2012
- First submitted
- 1 Jun 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT01365078
- Acronym / sponsor ID
- MEC 11-3-029
- Conditions
- Lipid Metabolism Disorders
- Keywords
- n-3 polyunsaturated fatty acids, Stearidonic acid, Lipid metabolism, Serum triacylglycerol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Bioriginal Europe / Asia B.V.
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Jun 2011 (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.
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus, providing oils rich in SDA may increase the endogenous synthesis of EPA. This may subsequently lower serum triacylglycerol concentrations, an effect frequently observed after EPA supplementation, especially in people with increased triacylglycerol levels.
The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol concentrations in healthy overweight and slightly obese men and women. The minor objective is to study the effects of echium oil on the omega-3 index, which is negatively related to cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.
Detailed description
Using a randomized, double-blind, placebo controlled crossover design, subjects will receive in random order for six weeks with a washout period of at least 14 days, daily 10 g of echium oil or a high-oleic acid sunflower oil (HOSO) as control.
Thirty-six healthy men and women, aged 18-70 yrs, with a body mass index between 25 and 35 kg/m2 will participate. Subjects with an increased BMI are at increased risk to develop hypertriglyceridemia.
During the experimental period, subjects will receive daily one sachet at lunch and one sachet at dinner each providing 5 g of echium oil. During the control period, subjects will receive daily at the same time points sachets with the same amount of HOSO.
The main study parameter is the change in fasting serum triacylglycerol concentrations. The secondary endpoint is the change in the omega-3 index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echium oil (SDA-rich oil) | Experimental | Dietary Supplement: Echium oil (SDA-rich oil) |
| High-oleic acid sunflower oil (HOSO) | Placebo comparator | Dietary Supplement: high-oleic acid sunflower oil (HOSO) (low in SDA)low in SDA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 18-70 years
- Quetelet-index between 25-35 kg/m2
- mean serum triacylglycerol < 3.0 mmol/L
Key exclusion criteria (11 listed)
- unstable body weight (weight gain or loss >2 kg in the past 3 months)
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
- use of medication or a diet known to affect serum lipid or glucose metabolism
- active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebrovascular accident)
- severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis
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 |
|---|---|---|
| Echium oil (SDA-rich oil)Also: Oil rich in Stearidonic acidThe echium oil will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the experimental period twice a day, i.e. one sachet at lunch and one sachet at dinner | Dietary supplement | Echium oil (SDA-rich oil) |
| high-oleic acid sunflower oil (HOSO) (low in SDA)Also: Oil low in Stearidonic acidThe HOSO will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the control period twice a day, i.e. one sachet at lunch and one sachet at dinner | Dietary supplement | High-oleic acid sunflower oil (HOSO) |
Primary outcome
fasting serum triacylglycerol concentrations
Time frame: Measured in week 1, 3,5 and 6 of the experimental and the control period
1 secondary outcome
omega-3 index
Time frame: Measured in week 1, 3, 5 and 6 of the experimental and the control period
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 8 Mar 2012.
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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.
Ronald P Mensink, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echium oil (SDA-rich oil) and high-oleic acid sunflower oil (HOSO) (low in SDA) in people with Lipid Metabolism Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 11 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
fasting serum triacylglycerol concentrations (time frame: Measured in week 1, 3,5 and 6 of the experimental and the control period). 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 8 Mar 2012.