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Stearidonic Acid and Lipid Metabolism

Primary Purpose

Lipid Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Echium oil (SDA-rich oil)
high-oleic acid sunflower oil (HOSO) (low in SDA)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lipid Metabolism Disorders focused on measuring n-3 polyunsaturated fatty acids, Stearidonic acid, Lipid metabolism, Serum triacylglycerol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Echium oil (SDA-rich oil)

High-oleic acid sunflower oil (HOSO)

Arm Description

low in SDA

Outcomes

Primary Outcome Measures

fasting serum triacylglycerol concentrations

Secondary Outcome Measures

omega-3 index
The proportion of EPA and DHA in red blood cells

Full Information

First Posted
June 1, 2011
Last Updated
March 7, 2012
Sponsor
Maastricht University Medical Center
Collaborators
Bioriginal Europe / Asia B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01365078
Brief Title
Stearidonic Acid and Lipid Metabolism
Official Title
Effects of Stearidonic Acid on Serum Triacylglycerol Concentrations in Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Bioriginal Europe / Asia B.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders
Keywords
n-3 polyunsaturated fatty acids, Stearidonic acid, Lipid metabolism, Serum triacylglycerol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echium oil (SDA-rich oil)
Arm Type
Experimental
Arm Title
High-oleic acid sunflower oil (HOSO)
Arm Type
Placebo Comparator
Arm Description
low in SDA
Intervention Type
Dietary Supplement
Intervention Name(s)
Echium oil (SDA-rich oil)
Other Intervention Name(s)
Oil rich in Stearidonic acid
Intervention Description
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
Intervention Name(s)
high-oleic acid sunflower oil (HOSO) (low in SDA)
Other Intervention Name(s)
Oil low in Stearidonic acid
Intervention Description
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
Primary Outcome Measure Information:
Title
fasting serum triacylglycerol concentrations
Time Frame
Measured in week 1, 3,5 and 6 of the experimental and the control period
Secondary Outcome Measure Information:
Title
omega-3 index
Description
The proportion of EPA and DHA in red blood cells
Time Frame
Measured in week 1, 3, 5 and 6 of the experimental and the control period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 ER
Country
Netherlands

12. IPD Sharing Statement

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Stearidonic Acid and Lipid Metabolism

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