Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:56 PM
Study NCT ID:
NCT07034794
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of post-emergent adverse events (AE)', 'timeFrame': 'Day 0 to 112', 'description': 'Incidence of post-emergent adverse events (AE)'}, {'measure': 'Clinically relevant changes in blood pressure after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in blood pressure after supplementation'}, {'measure': 'Clinically relevant changes in heart rate after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in heart rate after supplementation'}, {'measure': 'Clinically relevant changes in clinical chemistry', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) after supplementation'}, {'measure': 'Clinically relevant changes in clinical chemistry', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in total bilirubin after supplementation'}, {'measure': 'Clinically relevant changes in clinical chemistry', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in creatinine after supplementation'}, {'measure': 'Clinically relevant changes in clinical chemistry', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in estimated glomerular filtration rate (eGFR) after supplementation'}, {'measure': 'Clinically relevant changes in clinical chemistry', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in glucose after supplementation'}, {'measure': 'Clinically relevant changes in complete blood count after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in complete blood count after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in triglycerides (TG) after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in total cholesterol (TC) after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in high-density lipoprotein cholesterol (HDL-C) after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in non-HDL-C after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in low-density lipoprotein cholesterol (LDL-C), (TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios) after supplementation'}, {'measure': 'Clinically relevant changes in lipid profile after supplementation', 'timeFrame': 'Day 0 to 112', 'description': 'Clinically relevant changes in oxidized LDL (oxLDL)\\* after supplementation'}, {'measure': 'Inflammatory markers as assessed by C-reactive protein (CRP)', 'timeFrame': 'Day 0 to 112', 'description': 'Inflammatory markers as assessed by C-reactive protein (CRP)'}, {'measure': 'The difference in change in LPC-DHA and LPC-EPA', 'timeFrame': 'Day 14 to 112', 'description': 'The difference in change in LPC-DHA and LPC-EPA from baseline at Days 14 and 112'}, {'measure': 'The difference in change in biological age, as assessed by epigenetic analysis', 'timeFrame': 'Day 0 to 112', 'description': 'The difference in change in biological age, as assessed by epigenetic analysis at baseline and Day 112'}], 'primaryOutcomes': [{'measure': 'The difference in change in episodic, working and spatial memory', 'timeFrame': 'Day 0 (baseline) to 112', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The difference in the change in episodic, working and spatial memory', 'timeFrame': 'Day 0 to 14', 'description': '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.'}, {'measure': 'The difference in the change in executive function', 'timeFrame': 'Day 0 to 14', 'description': '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.'}, {'measure': 'The difference in the change in executive function', 'timeFrame': 'Day 0 to 112', 'description': '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.'}, {'measure': 'The difference in the change in reaction time', 'timeFrame': 'Day 0 to 14', 'description': '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.'}, {'measure': 'The difference in the change in memory', 'timeFrame': 'Day 0 to 112', 'description': '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.'}, {'measure': 'The difference in the change in mood', 'timeFrame': 'Day 0 to 14', 'description': '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".'}, {'measure': 'The difference in the change in mood', 'timeFrame': 'Day 0 to 112', 'description': '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".'}, {'measure': 'The difference in the change in omega-3 status', 'timeFrame': 'Day 0 to 56', 'description': '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.'}, {'measure': 'The difference in the change in omega-3 status', 'timeFrame': 'Day 0 to 112', 'description': '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.'}, {'measure': 'The difference in the change in serum brain-derived neurotrophic factor (BDNF)', 'timeFrame': 'Day 0 to 56', 'description': 'The difference in the change from baseline between Lysoveta and placebo in serum brain-derived neurotrophic factor (BDNF) at Day 56'}, {'measure': 'The difference in the change in serum brain-derived neurotrophic factor (BDNF)', 'timeFrame': 'Day 0 to 112', 'description': 'The difference in the change from baseline between Lysoveta and placebo in serum brain-derived neurotrophic factor (BDNF) at Day 112'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lysoveta', 'Memory Problems', 'Hydrolyzed krill oil'], 'conditions': ['Healthy', 'Memory Problems']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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:\n\nWhat 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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females between 50 and 75 years, inclusive\n2. 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\n\n Or,\n\n 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:\n * 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)\n * Double-barrier method\n * Intrauterine devices\n * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)\n * Vasectomy of partner at least 6 months prior to screening\n * Abstinence and agrees to use contraception if planning on becoming sexually active during the study\n3. Self-reported memory problems as assessed by a combined score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening\n4. Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits\n5. 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\n6. Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits\n7. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study\n8. Agrees to avoid travelling between two or more time zones within one week of in-clinic visits\n9. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits\n10. Provided voluntary, written, informed consent to participate in the study\n11. Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients, including seafood and/or shellfish\n3. 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\n4. 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\n5. Regularly consumes two or more servings of fatty fish per week as assessed by the QI\n6. Self-reported color blindness/weakness as assessed by the QI\n7. Current employment that calls for overnight shiftwork as assessed by the QI\n8. Postmenopausal confusion, as assessed by the QI\n9. Unstable metabolic disease or chronic diseases as assessed by the QI\n10. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI\n11. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)\n12. Type I diabetes\n13. 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\n14. 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\n15. 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\n16. 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\n17. 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\n18. 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\n19. Individuals with an autoimmune disease or are immune compromised as assessed by the QI\n20. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI\n21. Self-reported confirmation of blood/bleeding disorders as assessed by the QI\n22. Use of medical cannabinoid products\n23. Chronic use of cannabinoid products (\\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period\n24. Irregular use of tobacco or nicotine products in the past one month, as assessed by the QI\n25. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n26. Alcohol or drug abuse within the last 12 months\n27. 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)\n28. Clinically significant abnormal laboratory results at screening as assessed by the QI\n29. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit\n30. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\n31. Individuals who are unable to give informed consent\n32. 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"}, 'identificationModule': {'nctId': 'NCT07034794', 'briefTitle': 'A Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aker BioMarine Human Ingredients AS'}, 'officialTitle': 'A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems', 'orgStudyIdInfo': {'id': '25AKCFA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lysoveta', 'description': 'This group receives 3 capsules containing 500 mg/capsule of Lysoveta, a hydrolyzed krill oil rich in omega-3 fatty acid bound to lysophosphatidylcholine.', 'interventionNames': ['Dietary Supplement: Lysoveta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This group receives medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil daily.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lysoveta', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The Lysoveta capsules contain 500 mg of lysophosphatidylcholine-rich oil extract of Antarctic krill.', 'armGroupLabels': ['Lysoveta']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo capsules contain medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6B3L1', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marc Moulin, PhD', 'role': 'CONTACT', 'email': 'mmoulin@kgkscience.com', 'phone': '2267819094'}, {'name': 'David Crowley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KGK Science Inc.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Marc Moulin, PhD', 'role': 'CONTACT', 'email': 'mmoulin@kgkscience.com', 'phone': '+12267819094;ext=300'}], 'overallOfficials': [{'name': 'David Crowley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KGK Science Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aker BioMarine Human Ingredients AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KGK Science Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}