Lysoveta for Memory Loss

Overseen By Marc Moulin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aker BioMarine Human Ingredients AS

Must not be taking: Cannabinoids, Insulin, others

Disqualifiers: Dementia, Schizophrenia, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of Lysoveta, a krill oil supplement, on memory in healthy adults who feel their memory has declined. Participants will take either Lysoveta or a placebo (a treatment with no active ingredient) and complete surveys to assess memory and mood. It is ideal for those aged 50-75 who have noticed memory issues and can maintain certain lifestyle habits during the study.

As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the potential benefits of Lysoveta on memory.

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

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible throughout the study. However, if you are using prescribed or over-the-counter medications that may impact the study, you might need to adjust them as assessed by the Qualified Investigator.

Is there any evidence suggesting that Lysoveta is likely to be safe for humans?

Research has shown that Lysoveta, which contains omega-3 fatty acids, was tested for safety in earlier studies. The Food and Drug Administration (FDA) has approved Lysoveta as a safe omega-3 supplement for adults. This approval supports its safety, but individual reactions may vary.

Other studies have not identified any major side effects from taking Lysoveta. Most participants in these studies tolerated the supplement well, without serious issues. This suggests that Lysoveta is likely safe for similar groups.

Overall, Lysoveta appears well-tolerated based on past research and its FDA approval. However, consulting a healthcare provider about potential risks before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Lysoveta is unique because it combines hydrolyzed krill oil rich in omega-3 fatty acids with lysophosphatidylcholine, a combination not found in current memory loss treatments. Most existing treatments for memory loss, like cholinesterase inhibitors, focus on altering brain chemicals to improve symptoms. However, Lysoveta works differently by potentially leveraging omega-3's anti-inflammatory and neuroprotective properties to support brain health. Researchers are excited about Lysoveta's novel approach, as it could offer a more natural way to enhance cognitive function and slow memory decline.

What evidence suggests that Lysoveta might be an effective treatment for memory loss?

Research has shown that Lysoveta, a type of krill oil, might improve memory by delivering important omega-3 fatty acids, such as EPA and DHA, directly to the brain. These nutrients are essential for brain health and may aid in thinking and memory. Studies in mice have found that diets rich in similar nutrients can increase DHA levels in the brain and improve memory-related behaviors. While research in humans continues, this trial will evaluate Lysoveta's potential to maintain or boost memory function. Participants will receive either Lysoveta or a placebo to assess its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who feel like they are experiencing memory problems. Participants should not have any diagnosed cognitive disorders but believe their memory isn't as good as it used to be.

Inclusion Criteria

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study

Self-reported memory problems as assessed by a combined score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening

Agrees to avoid first generation anti-allergy medication for 48 hours prior to in-clinic visits

Exclusion Criteria

Regularly consumes two or more servings of fatty fish per week as assessed by the QI

Self-reported color blindness/weakness as assessed by the QI

Unstable metabolic disease or chronic diseases as assessed by the QI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Lysoveta or placebo and complete cognitive performance and mood questionnaires

16 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lysoveta

Trial Overview The trial is testing Lysoveta, a krill oil supplement, against a placebo to see if it improves memory functions such as episodic, working, and spatial memory in participants with self-perceived memory issues.

How Is the Trial Designed?

Group I: Lysoveta Experimental Treatment 1 Intervention

This group receives 3 capsules containing 500 mg/capsule of Lysoveta, a hydrolyzed krill oil rich in omega-3 fatty acid bound to lysophosphatidylcholine.

Group II: Placebo Placebo Group 1 Intervention

This group receives medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil daily.

Who Is Running the Clinical Trial?

Aker BioMarine Human Ingredients AS

Lead Sponsor

Trials

9

Recruited

1,700+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07034794

A Clinical Trial to Examine Lysoveta on Cognitive Function ... The study is a randomized, placebo-controlled, triple-blind, parallel group trial, in which the effect of krill oil is investigated in healthy volunteers ...

2. nutraceuticalbusinessreview.com nutraceuticalbusinessreview.com/aker-biomarine-lysoveta-clinical-trial-kgk-science

Aker BioMarine taps CRO KGK Science for Lysoveta ... The clinical trial will assess if Lysoveta can effectively deliver omega-3 fatty acids EPA and DHA to the brain and eyes.

3. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/Lysophosphatidylcholine-Omega3_(supplement).pdf

Lysophosphatidylcholine-Omega3 Human research to suggest prevention of dementia, prevention of decline, or improved cognitive function: Omega-3 PUFA are essential for brain structure and ...

4. fenixhealthscience.com fenixhealthscience.com/blogs/news/what-is-lysoveta-the-innovative-omega-3-for-targeted-health-benefits?srsltid=AfmBOorWCchVISG8Xzz8MOmYbwo1IJjZsDqKG-Ly4xRGPueFJeH86waO

What is Lysoveta? The Innovative Omega-3 for Targeted ... Better absorption of EPA and DHA in our brain and eye tissues. · Increased support by providing cognitive and visual health benefits.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8282213/

LPC-DHA/EPA-Enriched Diets Increase Brain ... Our data demonstrate that LPC-DHA/EPA-enriched krill oil can increase brain DHA and improve memory-relevant behavior in mice that express APOE4.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06933095

Optimizing CNS DHA Delivery in Elderly Adults at Risk for ... The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood ...

7. fenixhealthscience.com fenixhealthscience.com/blogs/news/what-is-lysoveta-the-innovative-omega-3-for-targeted-health-benefits?srsltid=AfmBOoqY_THGiy4GXf67ZzLPyeC8dRAIQ9FJPTHc6r1ZkIBR781JYTPM

What is Lysoveta? The Innovative Omega-3 for Targeted ... The Food and Drug Administration's (FDA) approval of Lysoveta® means that it's a safe and effective omega-3 supplement for adults. The NDI ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11279425/

Dietary LPC-Bound n-3 LCPUFA Protects against Neonatal ... Oral Lysoveta diminished gray and white matter injury but did not ameliorate functional deficits following HI. Lysoveta did not further enhance the therapeutic ...