Actively Recruiting
A 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
38 weeks
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
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
Official 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 between 50 and 75 years, inclusive
- Females not of child-bearing potential or using approved birth control methods
- Self-reported memory problems with an Everyday Memory Questionnaire score of 6 or higher
- Agreement to avoid moderate-vigorous exercise 12 hours before clinic visits
- Agreement to avoid high caffeine, NSAIDs, and alcohol for 24 hours before clinic visits
- Agreement to avoid first generation anti-allergy medication for 48 hours before clinic visits
- Commitment to maintain current lifestyle habits throughout the study
- Agreement to avoid travel across two or more time zones within one week of clinic visits
- Willingness to complete questionnaires, records, diaries, and all clinic visits
- Provided written informed consent
- Healthy as determined by medical history and lab results assessed by the Qualified Investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance to investigational product or placebo ingredients including seafood/shellfish
- Dementia or significant cognitive impairment with MMSE-2 score below 24
- Significant neuropsychological conditions or cognitive impairments that interfere with participation
- Regular consumption of two or more servings of fatty fish per week
- Color blindness or weakness
- Employment involving overnight shift work
- Postmenopausal confusion
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension unless stable on medication for 3 months
- Type I diabetes
- Type II diabetes if on insulin treatment
- Recent significant cardiovascular events
- Kidney or liver diseases with exceptions
- Current or pre-existing thyroid conditions unless stable on medication
- Major surgery in past 3 months or planned surgery during study
- Cancer except fully excised skin basal cell carcinoma or cancer in remission over five years
- Autoimmune diseases or immune compromise
- HIV, Hepatitis B or C positive
- Blood or bleeding disorders
- Use of medical cannabinoid products or chronic cannabinoid use
- Irregular tobacco or nicotine use in past month
- Alcohol intake averaging more than 2 standard drinks per day
- Alcohol or drug abuse within last 12 months
- Use of medications, supplements, or foods that may affect study product
- Clinically significant abnormal lab results at screening
- Blood donation within 30 days before or planned during study
- Participation in other clinical studies within 30 days
- Unable to give informed consent
- Any condition or lifestyle factor that may affect study completion or pose risk per Qualified Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
CONTACT
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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