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?
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
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
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
Aker BioMarine Human Ingredients AS
Lead sponsor
KGK Science Inc.
Collaborator