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CompletedNCT01544855Updated Mar 3, 2014

Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?

An interventional study of omega-3 fatty acids in Healthy, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-03.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
20 Years to 35 Years
Sex
All
01

Study summary

Genetics and nutrition both clearly affect the risk of Alzheimer's disease (AD) in the elderly. Apolipoprotein E (APOE4) is the most important known genetic risk for AD and is prevalent in 20-25% of Canadians, but at present, knowing an individual's ApoE genotype does not help the diagnosis, treatment or prevention of AD. Furthermore, fish intake containing docosahexaenoic acid (DHA, 22:6 omega-3) and eicosapentaenoic acid (EPA, 20:5 omega-3) may be incorporated as a prevention strategy for lowering the risk of AD. However, fish intake seems not to protect APOE4 carriers from developing AD. One explanation as to why APOE4 carriers may not benefit from fish intake is potentially linked with imbalances in omega-3 fatty acid metabolism. The investigators recently reported that after 3g/d of EPA+DHA for 6 weeks, increases in the two fatty acids was less for carriers resulting in a significant gene-by-diet interaction. ApoE is a component of lipoproteins and ApoE genotypes modulate the fasting lipoprotein response to fish-oil supplementation. Therefore, the investigators hypothesis is that APOE4 genotype is associated with imbalances in lipoprotein concentrations which has the consequence to be associated with imbalances in EPA and DHA transport. The investigators will recruit and test 100 healthy young adults since at older ages carriers of ApoE4 usually take medication altering their lipoprotein profile. They will receive an EPA + DHA supplement for one month. This period was chosen because the 3 class of lipoproteins (VLDL, LDL and HDL) have different concentrations in TG, phospholipids and cholesteryl esters and to fully investigate lipoprotein fatty acid changes, one month of supplementation is needed to change EPA and DHA in all lipid classes. The investigators will monitor the distribution of EPA and DHA in the lipoproteins over a one month supplementation with fish oil and the investigators will separate the investigators groups by APOE4 carriers and non-carriers.

02

Conditions studied

  • Healthy

Keywords

  • Health young participants
03

In context

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Fifty healthy men and fifty healthy women aged between 20-35 y old will be recruited.

Exclusion criteria

Exclusion Criteria:

  • Tobacco
  • Medication (except for oral contraceptives)
  • EPA+DHA supplements
  • Cancer
  • Recent major surgery (\< 2 years)
  • Ongoing or past severe drug or alcohol abuse
  • History of psychiatric difficulties or depression
  • Allergy to seafood
  • Elite level of physical training
  • Pregnancy and breastfeeding
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    APOE4 carriers

    The results obtained for APOE4 carriers will be compared to the one obtained from APOE4 non-carriers. Carriers are defined as being at least carrier of one APOE4 allele.

    Dietary Supplement: omega-3 fatty acids

Interventions

  • Dietary supplementomega-3 fatty acids

    Participants will take 700 mg/d of EPA and 500 mg/d of DHA as ethyl esters for one month (Ocean Nutrition, Dartmouth, NS) which is about 10 times the current estimated intake of young adults (21). This corresponds to one capsule with breakfast and one capsule with diner.

06

What researchers measure

Primary outcomes

  1. Distribution of EPA and DHA in lipoproteins by APOE genotype

    We will measure % and concentration of EPA and DHA in VLDL, HDL and LDL to evaluate how these fatty acids are transported in the blood and whether APOE genotype changes the distribution of these fatty acids.

    Time frame: Once each week for 28 days

07

Study locations

1 site
  • Centre de recherche sur le vieillissement
    Sherbrooke, Quebec J1H4C4, Canada
08

References and documents

Publications

  • Conway V, Allard MJ, Minihane AM, Jackson KG, Lovegrove JA, Plourde M. Postprandial enrichment of triacylglycerol-rich lipoproteins with omega-3 fatty acids: lack of an interaction with apolipoprotein E genotype? Lipids Health Dis. 2014 Sep 16;13:148. doi: 10.1186/1476-511X-13-148. PubMed 25227179 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01544855
Lead sponsor
Université de Sherbrooke
Responsible party
Mélanie Plourde (Assistant Professor, Université de Sherbrooke) — Principal investigator
First posted
Mar 6, 2012
Start date
Feb 2011
Primary completion
May 2012
Completion
May 2012
Last update
Mar 3, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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