Stearidonic Acid and Lipid Metabolism

This study has been completed.
Sponsor:
Collaborator:
Bioriginal Europe / Asia B.V.
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01365078
First received: June 1, 2011
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention
Lipid Metabolism Disorders
Dietary Supplement: Echium oil (SDA-rich oil)
Dietary Supplement: high-oleic acid sunflower oil (HOSO) (low in SDA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • fasting serum triacylglycerol concentrations [ Time Frame: Measured in week 1, 3,5 and 6 of the experimental and the control period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • omega-3 index [ Time Frame: Measured in week 1, 3, 5 and 6 of the experimental and the control period ] [ Designated as safety issue: No ]
    The proportion of EPA and DHA in red blood cells


Enrollment: 36
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365078

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Bioriginal Europe / Asia B.V.
Investigators
Principal Investigator: Ronald P Mensink, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01365078     History of Changes
Other Study ID Numbers: MEC 11-3-029
Study First Received: June 1, 2011
Last Updated: March 7, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
n-3 polyunsaturated fatty acids
Stearidonic acid
Lipid metabolism
Serum triacylglycerol

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Sphingolipidoses
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Genetic Diseases, Inborn
Lipid Metabolism, Inborn Errors
Lipidoses
Lysosomal Storage Diseases
Lysosomal Storage Diseases, Nervous System
Metabolism, Inborn Errors
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014