NCT01365078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

June 1, 2011

Last Update Submit

March 7, 2012

Conditions

Lipid Metabolism Disorders

Keywords

n-3 polyunsaturated fatty acidsStearidonic acidLipid metabolismSerum triacylglycerol

Outcome Measures

Primary Outcomes (1)

  • fasting serum triacylglycerol concentrations

    Measured in week 1, 3,5 and 6 of the experimental and the control period

Secondary Outcomes (1)

  • omega-3 index

    Measured in week 1, 3, 5 and 6 of the experimental and the control period

Study Arms (2)

Echium oil (SDA-rich oil)

EXPERIMENTAL
Dietary Supplement: Echium oil (SDA-rich oil)

High-oleic acid sunflower oil (HOSO)

PLACEBO COMPARATOR

low in SDA

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

Interventions

Echium oil (SDA-rich oil)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

Also known as: Oil rich in Stearidonic acid
Echium oil (SDA-rich oil)
high-oleic acid sunflower oil (HOSO) (low in SDA)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

Also known as: Oil low in Stearidonic acid
High-oleic acid sunflower oil (HOSO)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

stearidonic acid

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ronald P Mensink, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

NL(1)