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Recruiting NCT07034794

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

Conditions: Healthy, Memory Problems

Sex: All
Ages: 50 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 138
Sponsor: Aker BioMarine Human Ingredients AS

Location: KGK Science Inc. London Ontario

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?

Eligibility Criteria

Inclusion Criteria: 1. Males and females between 50 and 75 years, inclusive 2. 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 3. Self-reported memory problems as assessed by a combined score of ≥ 6 on Everyday Memory Questionnaire (EMQ) questions 1, 2 and 18 at screening 4. Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits 5. 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 6. Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits 7. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 8. Agrees to avoid travelling between two or more time zones within one week of in-clinic visits 9. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits 10. Provided voluntary, written, informed consent to participate in the study 11. Healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) Exclusion Criteria: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients, including seafood and/or shellfish 3. 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 4. 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 5. Regularly consumes two or more servings of fatty fish per week as assessed by the QI 6. Self-reported color blindness/weakness as assessed by the QI 7. Current employment that calls for overnight shiftwork as assessed by the QI 8. Postmenopausal confusion, as assessed by the QI 9. Unstable metabolic disease or chronic diseases as assessed by the QI 10. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI 11. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3) 12. Type I diabetes 13. Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of \2 times/week). Occasional users will be required to washout and abstain for the duration of the study period 24. Irregular use of tobacco or nicotine products in the past one month, as assessed by the QI 25. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 26. Alcohol or drug abuse within the last 12 months 27. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy or safety of the investigational product (Section 7.3) 28. Clinically significant abnormal laboratory results at screening as assessed by the QI 29. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 30. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 31. Individuals who are unable to give informed consent 32. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07034794). StuddyBuddy aggregates publicly available trial information.