Actively Recruiting
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
Led by Aker BioMarine Human Ingredients AS · Updated on 2026-01-09
138
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aker BioMarine Human Ingredients AS
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Lysoveta, a hydrolyzed krill oil rich in omega-3 fatty acids, on cognitive function in healthy adults aged 50 to 75 who have self-perceived memory problems. This randomized, placebo-controlled, triple-blind trial aims to understand differences in episodic, working, and spatial memory between those taking Lysoveta and those taking a placebo over the study period. Participants are randomly assigned to one of two groups: one group receives three capsules daily of Lysoveta, each containing 500 mg of lysophosphatidylcholine-rich Antarctic krill oil, while the other group receives placebo capsules containing medium-chain triglyceride oil, maize oil, olive oil, and palm kernel oil. The study spans 112 days during which cognitive performance and mood are assessed at multiple time points. Throughout the trial, volunteers complete questionnaires to evaluate memory and mood changes. Researchers will measure primary outcomes focusing on changes in memory from baseline to day 112, along with secondary outcomes including executive function, reaction time, omega-3 levels, and brain-derived neurotrophic factor at various intervals. Participants are monitored for adherence and safety, with the total study duration lasting approximately 16 weeks.
CONDITIONS
Brief Title
A Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 50 to 75 years inclusive
- Females not of child-bearing potential or using approved birth control if of child-bearing potential
- Self-reported memory problems with a combined score of 6 or higher on specified Everyday Memory Questionnaire items
- Agreement to avoid moderate-vigorous exercise 12 hours before post-screening visits
- Agreement to avoid high caffeine, NSAIDs, alcohol 24 hours before post-screening visits
- Agreement to avoid first generation anti-allergy medication 48 hours before post-screening visits
- Commitment to maintain current lifestyle habits during the study
- Agreement to avoid traveling across two or more time zones within one week of visits
- Willingness to complete study questionnaires, records, diaries, and clinic visits
- Voluntary, written informed consent provided
- Healthy as determined by medical history and lab results assessed by Qualified Investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance to investigational product ingredients including seafood or shellfish
- Dementia or significant cognitive impairment with MMSE-2 score below 24
- Significant neuropsychological conditions or cognitive impairments affecting participation
- Regular consumption of two or more servings of fatty fish per week
- Self-reported color blindness or weakness
- Employment involving overnight shiftwork
- Postmenopausal confusion
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension unless on stable medication for 3 months
- Type I diabetes
- Type II diabetes on insulin treatment
- Recent significant cardiovascular events within 6 months
- Kidney or liver diseases with exceptions as assessed
- Thyroid conditions unless stable on medication for 3 months
- Major surgery within past 3 months or planned during study
- Cancer except certain skin cancers and those in remission over 5 years
- Autoimmune diseases or immune compromise
- HIV, Hepatitis B or C infection
- Blood or bleeding disorders
- Use or chronic use of cannabinoid products
- Recent irregular use of tobacco or nicotine
- Excessive alcohol intake or recent substance abuse
- Use of medications or supplements impacting study product efficacy or safety
- Abnormal lab results at screening
- Blood donation close to study visits
- Participation in other clinical trials recently
- Inability to give informed consent
- Any condition or lifestyle factor posing risk or study completion difficulty per Qualified Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 112 days
Participants receive either Lysoveta or placebo capsules daily to examine effects on cognitive function.
1 baseline visit and multiple follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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