Stearidonic Acid and Lipid Metabolism
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|ClinicalTrials.gov Identifier: NCT01365078|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : March 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lipid Metabolism Disorders||Dietary Supplement: Echium oil (SDA-rich oil) Dietary Supplement: high-oleic acid sunflower oil (HOSO) (low in SDA)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
|Experimental: Echium oil (SDA-rich oil)||
Dietary Supplement: Echium oil (SDA-rich oil)
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
Other Name: Oil rich in Stearidonic acid
Placebo Comparator: High-oleic acid sunflower oil (HOSO)
low in SDA
Dietary Supplement: high-oleic acid sunflower oil (HOSO) (low in SDA)
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
Other Name: Oil low in Stearidonic acid
- fasting serum triacylglycerol concentrations [ Time Frame: Measured in week 1, 3,5 and 6 of the experimental and the control period ]
- omega-3 index [ Time Frame: Measured in week 1, 3, 5 and 6 of the experimental and the control period ]The proportion of EPA and DHA in red blood cells
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365078
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6229 ER|
|Principal Investigator:||Ronald P Mensink, PhD||Maastricht University Medical Center|