ClinicalTrials.gg
RecruitingNCT07034794Updated Jul 8, 2026

A Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems

An interventional study of Lysoveta and Placebo in Healthy and Memory Problems, sponsored by Aker BioMarine Human Ingredients AS. Recruiting at 1 site in Canada. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Aker BioMarine Human Ingredients AS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

The study is a randomized, placebo-controlled, triple-blind, parallel group trial, in which the effect of krill oil is investigated in healthy volunteers with self-perceived memory problems. Volunteers are randomly allocated to the 2 study groups including placebo and Lysoveta. Over the whole study period, volunteers will be asked to complete questionnaires to evaluate cognitive performance and mood throughout the duration of the trial.

The goal of this clinical trial is to examine Lysoveta on cognitive function in healthy adults with self-perceived memory problems. The main question it aims to answer is:

What is the difference in change in episodic, working and spatial memory as assessed by the Computerized Mental Performance Assessment System (COMPASS) between Lysoveta and placebo?

02

Conditions studied

  • Healthy
  • Memory Problems

Browse trials for

Keywords

  • Lysoveta
  • Memory Problems
  • Hydrolyzed krill oil
03

In context

Memory Disorders

373 studies on the registry are indexed under Memory Disorders; 67 are open to participants now.

This study's planned enrollment of 138 is above the median of 72 across 298 interventional studies indexed under Memory Disorders.

Browse Memory Disorders studies →

Lead sponsor

Aker BioMarine Human Ingredients AS is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females between 50 and 75 years, inclusive
  2. Females not of , defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been for at least 1 year prior to screening

    Or,

    Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
    • Abstinence and agrees to use contraception if planning on becoming sexually active during the study
  3. Self-reported memory problems as assessed by a combined score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening
  4. Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits
  5. Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits
  6. Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
  7. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
  8. Agrees to avoid travelling between two or more time zones within one week of in-clinic visits
  9. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
  10. Provided voluntary, written, to participate in the study
  11. Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)

Exclusion criteria

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, or intolerance preventing consumption of product or placebo ingredients, including seafood and/or shellfish
  3. Dementia or other significant cognitive impairment as assessed by the -2 Standard Version (MMSE-2) with a score \< 24 at screening
  4. Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, depression, epileptic or other seizure-related disorders) that could interfere with study participation as assessed by the QI
  5. Regularly consumes two or more servings of fatty fish per week as assessed by the QI
  6. Self-reported color blindness/weakness as assessed by the QI
  7. Current employment that calls for overnight shiftwork as assessed by the QI
  8. confusion, as assessed by the QI
  9. Unstable metabolic disease or chronic diseases as assessed by the QI
  10. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  11. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
  12. Type I diabetes
  13. Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an of \<8.0% may be included after assessment by the QI on a case-by-case basis
  14. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
  15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
  16. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  17. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
  18. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  19. Individuals with an disease or are immune compromised as assessed by the QI
  20. Self-reported confirmation of a -, - and/or C-positive diagnosis as assessed by the QI
  21. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
  22. Use of medical cannabinoid products
  23. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
  24. Irregular use of tobacco or nicotine products in the past one month, as assessed by the QI
  25. Alcohol intake average of >2 standard drinks per day as assessed by the QI
  26. Alcohol or drug abuse within the last 12 months
  27. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy or safety of the investigational product (Section 7.3)
  28. abnormal laboratory results at screening as assessed by the QI
  29. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  30. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  31. Individuals who are unable to give
  32. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    Lysoveta

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

    Dietary Supplement: Lysoveta

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • Dietary supplementLysoveta

    The Lysoveta capsules contain 500 mg of lysophosphatidylcholine-rich oil extract of Antarctic krill.

  • OtherPlacebo

    The placebo capsules contain medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil.

06

What researchers measure

Primary outcomes

  1. The difference in change in episodic, working and spatial memory

    The difference in change in episodic, working and spatial memory as assessed by the Computerized Mental Performance Assessment System (COMPASS) from baseline at Day 112 between Lysoveta and placebo. COMPASS delivers randomly generated tasks for each participant that are selected from a wide range of pre-programmed standard cognitive tests based on the objective of the study.

    Time frame: Day 0 (baseline) to 112

Secondary outcomes

  1. The difference in the change in episodic, working and spatial memory

    The difference in the change from baseline between Lysoveta and placebo in Episodic, working and spatial memory as assessed by COMPASS at Day 14. COMPASS delivers randomly generated tasks for each participant that are selected from a wide range of pre-programmed standard cognitive tests based on the objective of the study.

    Time frame: Day 0 to 14

  2. The difference in the change in executive function

    The difference in the change from baseline between Lysoveta and placebo in executive function as assessed by COMPASS at Days 14. COMPASS delivers randomly generated tasks for each participant that are selected from a wide range of pre-programmed standard cognitive tests based on the objective of the study.

    Time frame: Day 0 to 14

  3. The difference in the change in executive function

    The difference in the change from baseline between Lysoveta and placebo in executive function as assessed by COMPASS at Days 112. COMPASS delivers randomly generated tasks for each participant that are selected from a wide range of pre-programmed standard cognitive tests based on the objective of the study.

    Time frame: Day 0 to 112

  4. The difference in the change in reaction time

    The difference in the change from baseline between Lysoveta and placebo in reaction time as assessed by COMPASS at Days 14. COMPASS delivers randomly generated tasks for each participant that are selected from a wide range of pre-programmed standard cognitive tests based on the objective of the study.

    Time frame: Day 0 to 14

  5. The difference in the change in memory

    The difference in the change from baseline between Lysoveta and placebo in memory as assessed by the Everyday Memory Questionnaire at Day 112. On a 5-point scale: 0 = never, 1 = less than once a week, 2 = once or twice a week, 3 = about once each day, 4 = several times in a day.

    Time frame: Day 0 to 112

  6. The difference in the change in mood

    The difference in the change from baseline between Lysoveta and placebo in mood as assessed by the Profile of Mood States (POMS) at Days 14. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. On a scale of "not at all" to "extremely".

    Time frame: Day 0 to 14

  7. The difference in the change in mood

    The difference in the change from baseline between Lysoveta and placebo in mood as assessed by the Profile of Mood States (POMS) at Days 14. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. On a scale of "not at all" to "extremely".

    Time frame: Day 0 to 112

  8. The difference in the change in omega-3 status

    The difference in the change from baseline between Lysoveta and placebo in omega-3 status as assessed by the Omega-3 Index (omega-3 blood concentration) at Days 56.

    Time frame: Day 0 to 56

  9. The difference in the change in omega-3 status

    The difference in the change from baseline between Lysoveta and placebo in omega-3 status as assessed by the Omega-3 Index (omega-3 blood concentration) at Days 112.

    Time frame: Day 0 to 112

  10. The difference in the change in serum brain-derived neurotrophic factor (BDNF)

    The difference in the change from baseline between Lysoveta and placebo in serum brain-derived neurotrophic factor (BDNF) at Day 56

    Time frame: Day 0 to 56

  11. The difference in the change in serum brain-derived neurotrophic factor (BDNF)

    The difference in the change from baseline between Lysoveta and placebo in serum brain-derived neurotrophic factor (BDNF) at Day 112

    Time frame: Day 0 to 112

Other outcomes

  1. Incidence of post-emergent adverse events (AE)

    Incidence of post-emergent adverse events (AE)

    Time frame: Day 0 to 112

  2. Clinically relevant changes in blood pressure after supplementation

    Clinically relevant changes in blood pressure after supplementation

    Time frame: Day 0 to 112

  3. Clinically relevant changes in heart rate after supplementation

    Clinically relevant changes in heart rate after supplementation

    Time frame: Day 0 to 112

  4. Clinically relevant changes in clinical chemistry

    Clinically relevant changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) after supplementation

    Time frame: Day 0 to 112

  5. Clinically relevant changes in clinical chemistry

    Clinically relevant changes in total bilirubin after supplementation

    Time frame: Day 0 to 112

  6. Clinically relevant changes in clinical chemistry

    Clinically relevant changes in creatinine after supplementation

    Time frame: Day 0 to 112

  7. Clinically relevant changes in clinical chemistry

    Clinically relevant changes in estimated glomerular filtration rate (eGFR) after supplementation

    Time frame: Day 0 to 112

  8. Clinically relevant changes in clinical chemistry

    Clinically relevant changes in glucose after supplementation

    Time frame: Day 0 to 112

  9. Clinically relevant changes in complete blood count after supplementation

    Clinically relevant changes in complete blood count after supplementation

    Time frame: Day 0 to 112

  10. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in triglycerides (TG) after supplementation

    Time frame: Day 0 to 112

  11. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in total cholesterol (TC) after supplementation

    Time frame: Day 0 to 112

  12. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in high-density lipoprotein cholesterol (HDL-C) after supplementation

    Time frame: Day 0 to 112

  13. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in non-HDL-C after supplementation

    Time frame: Day 0 to 112

  14. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in low-density lipoprotein cholesterol (LDL-C), (TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios) after supplementation

    Time frame: Day 0 to 112

  15. Clinically relevant changes in lipid profile after supplementation

    Clinically relevant changes in oxidized LDL (oxLDL)\* after supplementation

    Time frame: Day 0 to 112

  16. Inflammatory markers as assessed by C-reactive protein (CRP)

    Inflammatory markers as assessed by C-reactive protein (CRP)

    Time frame: Day 0 to 112

  17. The difference in change in LPC-DHA and LPC-EPA

    The difference in change in LPC-DHA and LPC-EPA from baseline at Days 14 and 112

    Time frame: Day 14 to 112

  18. The difference in change in biological age, as assessed by epigenetic analysis

    The difference in change in biological age, as assessed by epigenetic analysis at baseline and Day 112

    Time frame: Day 0 to 112

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Nov 2026, 11 months after the start.

Of 138 interventional studies with no phase under Memory Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2025
First posted
Jun 24, 2025
StartActual
Dec 6, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07034794
Lead sponsor
Aker BioMarine Human Ingredients AS
Collaborators
KGK Science Inc.
Responsible party
Sponsor
First posted
Jun 24, 2025
Start date
Dec 6, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 8, 2026

Study contacts

Marc Moulin, PhD
Contact
mmoulin@kgkscience.com
+12267819094;ext=300
David Crowley, MD
principal investigator · KGK Science Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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