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

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Examine Lysoveta on Cognitive Function in Healthy Adults With Self-perceived Memory Problems

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?

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 <8.0% may be included after assessment by the QI on a case-by-case basis
14. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
16. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
17. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
18. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
19. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
20. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
21. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
22. Use of medical cannabinoid products
23. Chronic use of cannabinoid products (>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