Stearidonic Acid and Lipid Metabolism

NCT ID: NCT01365078

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-02-29

Brief 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. 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.

Conditions

Lipid Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Echium oil (SDA-rich oil)

Group Type: EXPERIMENTAL

Echium oil (SDA-rich oil)

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: PLACEBO_COMPARATOR

high-oleic acid sunflower oil (HOSO) (low in SDA)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Oil rich in Stearidonic acid; Oil low in Stearidonic acid

Eligibility Criteria

Inclusion Criteria

• aged between 18-70 years
• Quetelet-index between 25-35 kg/m2
• mean serum triacylglycerol < 3.0 mmol/L

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bioriginal Europe / Asia B.V.

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald P Mensink, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

MEC 11-3-029

Identifier Type: -

Identifier Source: org_study_id