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
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: omega-3 fatty acids

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Does Incorporation of EPA and DHA in Lipoproteins Differ According to Apolipoprotein E Genotype?

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01544855

Locations
Canada, Quebec
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H4C4
Sponsors and Collaborators
Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Mélanie Plourde, Assistant Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01544855     History of Changes
Other Study ID Numbers: Centrum
Study First Received: February 24, 2012
Last Updated: February 27, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Health young participants

ClinicalTrials.gov processed this record on August 20, 2014