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

NCT07034794 | Recruiting

• 1 other identifier: 25AKCFA01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Healthy; Memory Problems

Keywords

Lysoveta; Memory Problems; Hydrolyzed krill oil

Outcome Measures

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.

  Day 0 (baseline) to 112

Secondary Outcomes (11)

• The difference in the change in episodic, working and spatial memory

  Day 0 to 14

• The difference in the change in executive function

  Day 0 to 14

• The difference in the change in executive function

  Day 0 to 112

• The difference in the change in reaction time

  Day 0 to 14

• The difference in the change in memory

  Day 0 to 112

Other Outcomes (18)

• Incidence of post-emergent adverse events (AE)

  Day 0 to 112

• Clinically relevant changes in blood pressure after supplementation

  Day 0 to 112

• Clinically relevant changes in heart rate after supplementation

  Day 0 to 112

Study Arms (2)

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.

Dietary Supplement: Lysoveta

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lysoveta DIETARY_SUPPLEMENT

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

Lysoveta

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Aker BioMarine Human Ingredients AS: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

+12267819094;ext=300; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 24, 2025
• Study Start: December 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-06

Locations

CA (1)