Welcome!
We know you might have questions about our research study.
Welcome to the Aker Biomarine Omega-3 Memory clinical study. This study is about improving cognition and memory through a natural product containing omega-3s derived from krill.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
In this video, you will find the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms and the Frequently Asked Questions.
Memory Improvement with Omega-3s Introduction Video
2.Please Review the ICF Form here.
Please review the Informed Consent Form. You do not need to sign this copy but will be required to sign an electronic copy when you decide to join the study and before screening can begin.
3. Frequently Asked Questions
What is the purpose of this clinical study?
The goal of this study is to assess the safety and effectiveness of Lysoveta (a dietary supplement containing ingredients derived from krill oil) on memory in healthy older adults.
What does "randomized" and "triple-blind" mean?
- Randomized means participants are assigned by chance—like flipping a coin—into one of two groups:
- Lysoveta group
- Placebo group
Triple-blind means you, the study team, and the data analysts won’t know which group you’re in. This helps keep the results fair and unbiased. However, if needed for your safety, the study staff can find out this information .
Placebo-controlled means that there are two groups in the study, where one group receives the study product, Lysoveta, while the other group receives a placebo, which looks the same, but has no active ingredients.
What do the study products contain?
- Both are provided in capsule form:
- Lysoveta full ingredients are as follows:
Active Ingredient | Quantity (per capsule) | Quantity (per day) |
Eicosapentaenoic acid (from hydrolyzed Antarctic krill oil) | 73 mg | 219 mg |
Docosahexaenoic acid (from hydrolyzed Antarctic krill oil) | 36 mg | 108 mg |
Total omega 3 fatty acids (from hydrolyzed Antarctic krill oil) | 130 mg | 390 mg |
Total Phospholipids (from hydrolyzed Antarctic krill oil) | 227 mg | 681 mg |
Total Lysophosphatidylcholine (from hydrolyzed Antarctic krill oil) | 152 mg | 456 mg |
Astaxanthin (from hydrolyzed Antarctic krill oil) | 72.4 µg | 217.2 µg |
Non-medicinal ingredients: gelatin, ethyl vanillin, water, iron oxide black, glycerol, sorbitol
Abbreviations :mg = Milligrams µg= Micrograms
- Placebo ingredients include:
- Ingredients: Medium chain triglycerides, palm kernel oil, maize oil, virgin olive oil, gelatin, ethyl vanillin, water, iron oxide black, glycerol, sorbitol
How often should I take the study product ?
- You will take three capsules daily for the duration of the study at the same time each day. It is recommended to take in the morning with food.
- Remember to save all used and unused packaging and return them to KGK Science Inc.
What if I miss a dose?
If you forget to take a dose, do not take it later the same day. Simply continue with your next regular dose of 1.5 g (3 capsules) at the usual time the following day. You must not take more than three capsules daily. Report any missed dose in your daily study diary.
Are there any side effects?
It is possible that you could have problems or side effects from the study that nobody knows about yet. Some side effects you could experience include:
- Gastrointestinal upsets, including: Bloating, upset stomach, Heartburn, Diarrhea, Loss of appetite, nausea, Change in stool color
- Headache
- Allergic reactions – please read study ingredients carefully to ensure you are not allergic to any of them, please note you should not participant in the study if you have an allergy or sensitivity to seafood or shellfish. Some effects of an allergic reaction that could be a sign of a life-threatening (anaphylaxis) include:
- Rash
- Difficulty of Breathing
- Wheezing
- Sudden drop in blood pressure (making you feel dizzy or lightheaded)
- Swelling around the mouth, throat, or eyes
- Fast pulse
- Sweating
Please contact the study staff in you have questions about the signs or symptoms of any side-effects you read about on this page
Is there anything I should know before coming to clinic?
Before your visits 2, 3, 4, and 5, you will be asked to:
- Avoid moderate to vigorous exercise for 12 hours before.
- Avoid caffeine (for example. supplements, tea, coffee, energy drinks, pop), alcohol, and non-steroidal anti-inflammatory drugs (NSAIDs) for 24 hours.
- Avoid first-generation anti-allergy medication (for example. Benadryl (diphenhydramine), Atarax (hydroxyzine), Gravol (dimenhydrinate) for 24 hours.
- Avoid travelling between two or more time zones within one week of your visit.
- You will also be asked to fast for at least 12 hours.
How long will the study last?
The study will last approximately 112 days after the initial screening visit. You will have 5 in clinic visits throughout the 112 day duration
Can I Leave the Study at Any Time?
- Yes, your participation is completely voluntary. You can leave the study at any time, for any reason, without penalty or losing access to other care.
What tests will I have during the study?
- As part of the study, you will undergo:
- Collection of blood samples (this can be done by drawing blood from a vein using a needle, or by pricking your fingertip with a lancet)
- Urine Pregnancy Test (if you are of childbearing potential)
- Some questionnaires and cognitive assessments
What will the study diaries consist of?
You will be required to complete online daily study diaries where you will report study product consumption, any adverse events, and changes in health, medications, or lifestyle habits.
What are the questionnaires and tests, and what do they consist of?
- Everyday Memory Questionnaire (EMQ) – Visit 1, 2 and 5 - This questionnaire asks about everyday memory problems. You will answer only 3 questions of this questionnaire at screening (visit 1). The full questionnaire will be applied at visits 2 and 5.
- Mini-Mental State Examination-2 Standard Version (MMSE-2) – Visit 1 - This questionnaire includes 30 questions that check different areas of cognition. It is used to assess if someone might have cognition impairment.
- Cognitive Mental Performance Assessment System (COMPASS) – Visit 2, 3, 4 and 5 - This assessment evaluates cognitive function. It gives each person a set of cognitive tasks randomly chosen from a pool of pre-programmed standard tests. The test will take approximately 40 minutes to complete.
- Profile of Mood States (POMS) – Visit 2, 3 and 5 – This tool is used to measure self-reported mood states.
Will my personal information be kept private?
Yes, absolutely. All your personal and medical information will be kept confidential to the extent required by law. You will not be identified in any publication that may result from the study.
Will there be any cost to me?
As part of the study, you will undergo:
Saliva samples will be collected for analysis of cortisol
Individuals of childbearing potential will have to undergo a Urine Pregnancy Test
Diaries, questionnaires, and computer-based tests
What is the compensation for participating?
- Yes, you will receive a total of $600 if you complete all study visits and requirements. Payments are made using a Clincard (like a prepaid Mastercard you can use for purchases or ATM withdrawals – ATM fees apply)
- Processing times may apply before funds become available on your Clincard
How and when will I receive my compensation for participation?
- Perceived Stress Scale (PSS) – this questionnaire will be used to measure how stressed you feel
- Computerized Mental Performance Assessment System (COMPASS) – This program will be used to assess your cognitive function which includes attention; episodic, spatial and working memory; psychomotor, processing and motor speed; and reaction time assessments
- GO/NO-GO Assessment – This is a computer-based test that measures your ability to stay focused and control your responses
- STANDARDIZED MEAL – You will consume identical meals—including the same portions—at Visit 2 and 3 comprised of the following options:
- Tomato soup and crackers
- Turkey and Swiss cheese OR Roasted vegetable and Swiss cheese sandwich on whole wheat bread
- Apple with peanut butter
- No herbal decaffeinated tea, decaffeinated coffee or juices will be allowed, however water will be provided.
Who do I contact if I have questions or concerns?
If you have any questions, you can reach out to our clinic at the following email address: clinic@kgkscience.com
What should I do in an emergency?
In case of an emergency, call 911 or go to the nearest emergency room right away. Inform the medical staff that you are taking part in a research study. As soon as you are able, contact the study team at KGK Science.
Reminder: Your participation is completely voluntary. Take your time, ask questions, and only join the study if you feel comfortable.
Thank you for your interest in our study! If anything is unclear or you need more information, don’t hesitate to reach out.