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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
The Lysoveta capsules contain 500 mg of lysophosphatidylcholine-rich oil extract of Antarctic krill.
The placebo capsules contain medium-chain triglyceride (MCT) oil, maize oil, olive oil, and palm kernel oil.
KGK Science Inc.
London, Ontario, Canada
RECRUITINGThe 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.
Time frame: Day 0 (baseline) to 112
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Day 0 to 112
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