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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mélanie Plourde, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01544855
First received: February 24, 2012
Last updated: February 27, 2014
Last verified: February 2014

February 24, 2012
February 27, 2014
February 2011
May 2012   (final data collection date for primary outcome measure)
Distribution of EPA and DHA in lipoproteins by APOE genotype [ Time Frame: Once each week for 28 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01544855 on ClinicalTrials.gov Archive Site
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Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?
Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?

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.

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Interventional
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Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Dietary Supplement: omega-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.
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.
Intervention: Dietary Supplement: omega-3 fatty acids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Both
20 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01544855
Centrum
Yes
Mélanie Plourde, Université de Sherbrooke
Université de Sherbrooke
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Université de Sherbrooke
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP