A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults (COG)
Cognitive Impairment, Cognitive Decline, Cognition Disorders in Old Age
About this trial
This is an interventional other trial for Cognitive Impairment focused on measuring cognitive function, inflammation, well being
Eligibility Criteria
Inclusion Criteria: Healthy adult participants who are 30 to 60 years of age (inclusive). In good general health (no active or uncontrolled diseases or conditions). Have a body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive). Have normal or acceptable to the investigator vital signs (blood pressure and heart rate) at screening and/or baseline. Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including: use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System); or use for at least 1 month prior to the first dose of study product: double-barrier method, intrauterine devices, or complete abstinence from sexual intercourse that can result in pregnancy; or vasectomy of partner at least 6 months prior to the first dose of study product. Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable. Agree to refrain from treatments listed in Section 6.4 in the defined timeframe. Willing to refrain from changing their diet or lifestyle significantly for the duration of the study. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures. Exclusion Criteria: 1. Participants who are lactating, pregnant or planning to become pregnant during the study. 2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications. 3. Received a vaccine for COVID-19 in the 2 weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis). 4. Participants with diagnosed type I or type II diabetes. 5. Having a history of heart disease, uncontrolled high blood pressure (≥140 mmHg systolic or ≥90 mmHg diastolic), renal or hepatic impairment/disease, major affective disorders, hepatic or renal dysfunction, unstable thyroid disease, immune disorders and/or immunocompromised (e.g. HIV/AIDS), cognitive impairment, neurological condition, or neurological disease, psychiatric disorder that required hospitalization in the past year, cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study. 6. Major surgery in 3 months prior to screening or planned major surgery during the course of the study. 7. Participant has a pacemaker or implantable cardiac defibrillator. 8. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestions (e.g. known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea). 9. Participant has a history of alcohol or substance abuse in the 12 months prior to screening. 10. Receipt or use of test product(s) in another research study within 28 days prior to baseline or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study. 11. Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Sites / Locations
- Exercise and Performance Nutrition Laboratory
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
LasoperinTM
Placebo
Active ingredients: Scutellaria baicalensis extract, 240 mg per capsule. Acacia catechu extract, 51 mg per capsule. With no less than 180 mg of baicalin, and no less than 30 mg of catechins from the above-mentioned extracts per capsule. Inactive ingredients: Maltodextrin 2 capsules per day Take twice per day with food and water, once in the morning and once in the evening. If a dose is missed the participant can consume it as soon as they remember within the day. This means that the participant may consume 2 capsules at once. If both capsules are missed for the day the participant should not consume 4 capsules the next day and should return to the normal dosage of one capsule in the morning and evening
Active ingredients: N/A Inactive ingredients: Microcrystalline cellulose 2 capsules per day Take twice per day with food and water, once in the morning and once in the evening. If a dose is missed the participant can consume it as soon as they remember within the day. This means that the participant may consume 2 capsules at once. If both capsules are missed for the day the participant should not consume 4 capsules the next day and should return to the normal dosage of one capsule in the morning and evening