160 Participants Needed

Omega-3 Supplements for Cognitive Health in ApoE4 Carriers

MP
Overseen ByMelanie Plourde, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Université de Sherbrooke
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

In Canada, \~17 millions of adults between 30-64 y old could benefit from a prevention strategy to lower the risk of Alzheimer's disease (AD). Although a lot of epidemiological studies reported positive cognitive outcomes in populations eating fish, there is skepticism about the link between docosahexaenoic acid (DHA), an omega-3 (OM3) fatty acid in fish and prevention of cognitive decline. This is largely because there is a disconnect between epidemiological, molecular and animal studies which generally favor a link between higher DHA intake and cognition whereas clinical DHA and fish oil trial seem not to support such as link. There are several knowledge gaps in this field that might explain why clinical trials were not successful. This project will focus on two major gaps : OM3 fatty acid metabolism and the blood-to-brain DHA link. OM3 supplements in cardiovascular disease have faced the same issues for decades but the more recent trials have now generated the clinical evidence supporting primary and secondary cardiovascular events reduction and a better risk to benefit balance of OM3 drugs compared to statins, for instance. What if, for cognitive decline, the target was missed because the supplement/drug formulations were not appropriately designed to target the brain? The investigators hypothesize that (i) E4 carriers display a faulty packaging of circulating OM3, leading to reduced bioavailability for brain cells, (ii) The use of new OM3 formulation can direct plasma DHA into brain compartments more readily available for the brain, thereby increasing brain DHA concentrations and improving cognition. Studies in mice and humans will be performed to test OM3 metabolism and the blood-to-brain DHA link. Ultimately the information generated in this research project will help to better design clinical trials in term of fatty acid formulation, expected level to reach in the plasma and the brain.

Research Team

MP

Melanie Plourde, PhD

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

This trial is for men and women aged 30-50 who are generally healthy. It's not for those with malnutrition, diabetes, chronic inflammation or immune conditions, cancer, recent major surgery or heart events, pregnant or breastfeeding women, pre/menopausal women, uncontrolled thyroid/renal/endocrine diseases, dementia sufferers, intense athletes or those with a history of severe substance abuse.

Inclusion Criteria

I am between 30 and 50 years old.

Exclusion Criteria

I do not have uncontrolled thyroid, kidney, or hormonal diseases.
You are currently doing or have recently done intense physical training.
I have cancer.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive new OM3 formulation to test OM3 metabolism and the blood-to-brain DHA link

12 weeks
7 visits (in-person) at baseline, 1, 2, 3, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • omega-3 phospholipids
  • omega-3 Triglycerides
Trial Overview The study tests if new omega-3 fatty acid formulations can better reach the brain in people carrying the Apolipoprotein E Epsilon 4 allele. The goal is to see if these formulations improve cognition by increasing brain DHA concentrations compared to standard supplements.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: ApoE4 non carriersExperimental Treatment2 Interventions
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.
Group II: ApoE4 carriersExperimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+
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