Omega-3 Supplements for Cognitive Health in ApoE4 Carriers

Overseen By Melanie Plourde, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: EPA+DHA supplements

Disqualifiers: Diabetes, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether new types of omega-3 supplements can improve brain health in individuals at risk of Alzheimer's disease, particularly those with the ApoE4 genetic marker. Researchers believe current supplements may not deliver enough omega-3 to the brain, so they are testing new formulations, including omega-3 phospholipids and omega-3 triglycerides, to determine their effectiveness. The trial includes participants aged 30-50 who do not smoke, have no major health issues like diabetes, and are not already taking omega-3 supplements or consuming large amounts of fish. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to better brain health solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking an EPA+DHA supplement or have certain health conditions, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3 supplements, such as omega-3 phospholipids and triglycerides, are generally safe for most people. Studies on omega-3's impact on brain health have found these supplements to be well-tolerated. For instance, participants taking omega-3s did not report more side effects than those who did not.

Some research also suggests that omega-3s might help reduce the risk of memory problems, particularly in individuals with certain genetic traits, like the ApoE4 gene, which is linked to a higher risk of Alzheimer's. While omega-3 supplements are not a guaranteed way to prevent these issues, they are considered safe to include in a healthy diet.

The FDA has approved omega-3 supplements for other uses, such as supporting heart health, which further supports their safety. It is important to consult a healthcare provider before starting any new supplement, especially if existing health conditions are present. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about omega-3 phospholipids and omega-3 triglycerides for cognitive health in ApoE4 carriers because these treatments harness the unique benefits of omega-3s, known for their brain-supporting properties. Unlike standard options like cholinesterase inhibitors or NMDA receptor antagonists, which mainly target neurotransmitter systems, these omega-3 formulations aim to protect and enhance brain cell function directly. Omega-3 phospholipids, in particular, are believed to integrate into cell membranes more efficiently, potentially offering a more direct route to improve neuronal health and cognitive function. This novel approach may provide a complementary or alternative pathway to support cognitive health, especially for those with genetic predispositions like ApoE4 carriers.

What evidence suggests that this trial's omega-3 treatments could be effective for cognitive health in ApoE4 carriers?

This trial will compare the effects of omega-3 phospholipids and omega-3 triglycerides on cognitive health in ApoE4 carriers. Studies have shown that consuming more omega-3 fatty acids, such as those found in fish, is linked to slower decline in memory and thinking for people with the ApoE4 gene, a risk factor for Alzheimer's disease. Research specifically found that omega-3s in phospholipid form may help slow brain shrinkage and memory loss. For omega-3s in triglyceride form, the evidence is less clear. Some studies suggest they might reduce the risk of memory problems, but others did not find improvements in thinking skills. Overall, omega-3s have potential, but their effectiveness may depend on their form and ability to reach the brain. ^{1 3 5 6 7}

Who Is on the Research Team?

Melanie Plourde, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: ApoE4 non carriers Experimental Treatment 2 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 carriers Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11321946/

Effects of APOE4 on Omega-3 Brain Metabolism Across the ... We discuss how APOE4 influences the metabolism of brain DHA across three distinct stages: preclinical AD with normal cognition (Stage I), prodromal AD or mild ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724001717

Baseline Findings of PreventE4: A Double-Blind Placebo ... In the VITACOG trial, the brain's atrophy rate, along with cognitive decline, were slowed by the intake of B vitamins and high levels of ω-3 fatty acids (34).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10447496/

The Relationship of Omega-3 Fatty Acids with Dementia ... A study has found an association between a higher intake of omega-3 fatty acids and slower rates of cognitive decline among APOE ε4 carriers ...

4. karger.com karger.com/dee/article/15/1/140/934533/Impact-of-the-Apolipoprotein-E-4-Allele-on

Impact of the Apolipoprotein E ε4 Allele on Cognition and ... In the present study, the APOE4 carriers exhibited lower cognitive ... outcomes related to ω-3 PUFA supplementation and cognitive health.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0163782723000462

Effects of DHA on cognitive dysfunction in aging and ... These studies suggest that early DHA supplementation may confer benefits to cognitively normal older adults carrying the ApoE4 gene.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3518784/

Dietary omega 3 polyunsaturated fatty acids and Alzheimer's ... N-3 PUFA could therefore contribute to lower the risk of cognitive impairment and dementia associated with high TG in ApoE4 carriers. However, the potential ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821809

ω-3 PUFA for Secondary Prevention of White Matter ... Although ω-3 effects on WML progression in APOE*E4 carriers did not reach significance, APOE*E4 carriers treated with ω-3 had significantly less ...