HealthyNCT07034794
A Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
A study testing Lysoveta in people with Healthy and Memory Problems, run by Aker BioMarine Human Ingredients AS at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Memory Problems
- What is being tested?
- Lysoveta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between 50 and 75 years, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal 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 birth control 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
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- 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
- 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 moderate-vigorous exercise 12 hours prior to post-screening clinic visits
- 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
- Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Agrees to avoid travelling between two or more time zones within one week of in-clinic visits
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients, including seafood and/or shellfish
- Dementia or other significant cognitive impairment as assessed by the Mini Mental State Exam-2 Standard Version (MMSE-2) with a score < 24 at screening
- 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
- 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
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- Current employment that calls for overnight shiftwork as assessed by the QI
- Postmenopausal confusion, as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- Type I diabetes
- Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of <8.0% may be included after assessment by the QI on a case-by-case basis
- 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
- 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
- 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
- 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
- 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
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Irregular use of tobacco or nicotine products in the past one month, as assessed by the QI
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- 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)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Marc Moulin, PhD, 2267819094, mmoulin@kgkscience.com
David Crowley, MD
About this study
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
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?
- Conditions
- Healthy, Memory Problems
- Being tested
- Lysoveta, Placebo
- Keywords
- Lysoveta, Memory Problems, Hydrolyzed krill oil
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LysovetaDietary supplement
The Lysoveta capsules contain 500 mg of lysophosphatidylcholine-rich oil extract of Antarctic krill.
PlaceboOther
The placebo capsules contain medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil.
| Study group | Role | What they receive |
|---|---|---|
| Lysoveta | Experimental | This group receives 3 capsules containing 500 mg/capsule of Lysoveta, a hydrolyzed krill oil rich in omega-3 fatty acid bound to lysophosphatidylcholine. Receives: Dietary Supplement: Lysoveta |
| Placebo | Placebo comparator | This group receives medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (baseline) to 112
Secondary outcomes (11)
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.
Measured: Day 0 to 14
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.
Measured: Day 0 to 14
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.
Measured: Day 0 to 112
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.
Measured: Day 0 to 14
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.
Measured: Day 0 to 112
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".
Measured: Day 0 to 14
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".
Measured: Day 0 to 112
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.
Measured: Day 0 to 56
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.
Measured: Day 0 to 112
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
Measured: Day 0 to 56
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
Measured: Day 0 to 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start6 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aker BioMarine Human Ingredients AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034794
- Sponsor's protocol ID
- 25AKCFA01
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
- ClinicalTrials.gov ID
- NCT07034794
- Acronym / sponsor ID
- 25AKCFA01
- Conditions
- Healthy, Memory Problems
- Keywords
- Lysoveta, Memory Problems, Hydrolyzed krill oil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Aker BioMarine Human Ingredients ASIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lysoveta | Experimental | Dietary Supplement: LysovetaThis group receives 3 capsules containing 500 mg/capsule of Lysoveta, a hydrolyzed krill oil rich in omega-3 fatty acid bound to lysophosphatidylcholine. |
| Placebo | Placebo comparator | Other: PlaceboThis group receives medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil daily. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females between 50 and 75 years, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal 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 birth control 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:
- Self-reported memory problems as assessed by a combined score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening
Key exclusion criteria (32 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients, including seafood and/or shellfish
- Dementia or other significant cognitive impairment as assessed by the Mini Mental State Exam-2 Standard Version (MMSE-2) with a score < 24 at screening
- 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
- Regularly consumes two or more servings of fatty fish per week as assessed by the QI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LysovetaThe Lysoveta capsules contain 500 mg of lysophosphatidylcholine-rich oil extract of Antarctic krill. | Dietary supplement | Lysoveta |
| PlaceboThe placebo capsules contain medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil. | Other | Placebo |
Primary outcome
The difference in change in episodic, working and spatial memory
Time frame: Day 0 (baseline) to 112
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.
11 secondary outcomes
The difference in the change in episodic, working and spatial memory
Time frame: Day 0 to 14
The difference in the change in executive function
Time frame: Day 0 to 14
The difference in the change in executive function
Time frame: Day 0 to 112
The difference in the change in reaction time
Time frame: Day 0 to 14
The difference in the change in memory
Time frame: Day 0 to 112
The difference in the change in mood
Time frame: Day 0 to 14
The difference in the change in mood
Time frame: Day 0 to 112
The difference in the change in omega-3 status
Time frame: Day 0 to 56
The difference in the change in omega-3 status
Time frame: Day 0 to 112
The difference in the change in serum brain-derived neurotrophic factor (BDNF)
Time frame: Day 0 to 56
The difference in the change in serum brain-derived neurotrophic factor (BDNF)
Time frame: Day 0 to 112
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lysoveta in people with Healthy and Memory Problems, run by Aker BioMarine Human Ingredients AS at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Moulin, PhD (+12267819094;ext=300, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in episodic, working and spatial memory (time frame: Day 0 (baseline) to 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.