Causal Relationships Between LC-omega-3-enriched Diet and Cognition

NCT01625195 | Completed DMC

• 1 other identifier: IRSC-2012
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

Nutrition is key to healthy aging for a number of diseases but the investigators have reported imbalances in the distribution of long chain omega-3 fatty acids (LC-omega-3) in the elderly and in the carriers of apolipoprotein E epsilon 4 (APOE4) isoform. Carrying APOE4 isoform is currently recognized as being the most important genetic risk factor of cognitive decline. The investigators believe that dysregulation of LC-omega-3 metabolism is intimately link with higher risk of cognitive decline. The current project will investigate whether there is a causal relationship between LC-omega-3-enriched diet and cognition using, on the one hand, a randomized double-blind placebo-controlled design and on the other hand, transgenic mice carrying human APOE4. In both study, the investigators will focus specifically on the distribution (level) of LC-omega-3 into lipoproteins with age and/or APOE4 isoform to evaluate whether dysfunctional transport of LC-omega-3 is associated with lower cognitive scores on visuospatial capacity, verbal fluency or working memory. In APOE4 mice, the investigators will evaluate LC-omega-3 brain uptake together with the level of LC-omega-3 in the brain membranes and the level of APOE protein within the brain. The present investigation will provide key basis for understanding how to develop nutritional strategies for healthy aging and the preservation of cognitive function.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in cognition

  Evaluate change in visuospatial, verbal fluency or working memory with dietary intake (placebo or fish oil treatment.

  baseline and 6 months

Secondary Outcomes (2)

• DHA level in plasma at baseline

  baseline

• Monthly DHA metabolism

  once per month for 6 month

Study Arms (2)

Omega-3 fatty acid supplement

PLACEBO COMPARATOR

This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4 x 1285 mg fish oil capsules/d, two capsules with eachthe breackfast and two capsules with dinner. The daily treatment will provide 1.4 g/d of DHA and 1.8 g/d of EPA (Ocean Nutrition Canada, Dartmouth, NS). All capsules will contain orange flavor to mask the fishy taste and odor of the LC-omega-3 oil and will be provided to the participants monthly.

Dietary Supplement: omega-3 fatty acid supplementation

Placebo

ACTIVE COMPARATOR

This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4 x 1285 mg capsules/d, two capsules with each of the main daily meals. The placebo will be composed of 50:50% corn/soybean oil as used in other randomized placebo-controlled trials.

Dietary Supplement: corn/soybean oil placebo

Interventions

omega-3 fatty acid supplementation DIETARY_SUPPLEMENT

This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4 x 1285 mg fish oil capsules/d, two capsules with each of the main daily meals. The placebo will be composed of corn/soybean oil as used in other randomized placebo-controlled trials. The daily treatment will provide 1.2 g/d of DHA and 2.4 g/d of EPA (Ocean Nutrition Canada, Dartmouth, NS). All capsules will contain citrus flavor to mask the fishy taste and odor of the LC-omega-3 oil and will be provided to the participants monthly.

Also known as: MEG-3, 40/20 (EPA/DHA)ethyl esters fish oil capsules

Omega-3 fatty acid supplement

corn/soybean oil placebo DIETARY_SUPPLEMENT

This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4x 1285 mg capsules/d, two capsulesat breackfast and two capsules at dinner. The placebo will be composed of corn/soybean oil as used in other randomized placebo-controlled trials.

Also known as: Meg-3 40:20 EPA:DHA ethyl esters

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female subjects aged between 20-80 years old

You may not qualify if:

• tobacco use,
• malnutrition (assessed from blood albumin, hemoglobin and lipids),
• subjects taking an EPA+DHA supplement for more than one month,
• swallowing problems,
• severe gastro-intestinal problems,
• diabetes,
• uncontrolled thyroid disease,
• severe renal failure,
• liver disease or any other endocrine disorder,
• medication that would affect lipoprotein metabolism,
• chronic immune condition or inflammation (CRP \> 10 mg/l, white cell count),
• cancer,
• recent major surgery or cardiac event,
• pregnant or lactating women,
• uncorrected visual or hearing problems,

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Laval University: collaborator

Study Sites (1)

PL Léveillé

Sherbrooke, Quebec, J1H4C4, Canada

Location

Related Publications (1)

• Loukil I, Aguilera EC, Vachon A, Leveille P, Plourde M. Sex, Body Mass Index, and APOE4 Increase Plasma Phospholipid-Eicosapentaenoic Acid Response During an omega-3 Fatty Acid Supplementation: A Secondary Analysis. J Nutr. 2024 May;154(5):1561-1570. doi: 10.1016/j.tjnut.2024.03.013. Epub 2024 Mar 19.

  PMID: 38513888 DERIVED

Study Officials

• Melanie Plourde, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 21, 2012
• Study Start: May 1, 2012
• Primary Completion: April 2, 2017
• Study Completion: December 2, 2017
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

CA (1)