Inflammation Clinical Trial
Official title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
The potential impact of various dietary ingredients to improve cognitive function, mood, well-being, and overall levels of affects are largely undetermined. The purpose of this study is to determine the effects of a combination of two dietary supplements, Scutellaria baicalensis and Acacia catech, on cognitive function, well-being, mood, cognitive interferences, and inflammation.
The proposed study design will be a randomized, double-blind, placebo-controlled, parallel design to evaluate the effect of the supplement on cognitive function, well-being, mood, cognitive interferences, and inflammation. Participants will complete a series of psychological questionnaires, cognitive assessments, and venous blood draws. Screening Visit (Visit 1) Upon arrival to the lab, participants will receive an informed consent document and will be required to give full consent before proceeding. Upon providing consent, participants will provide personal and emergency contact information before completing a health history form, exercise history form, and a physical activity questionnaire. Prior to this visit and each subsequent visit, participants will be required to observe an overnight fast (8-10 hours) of food or drink with calories including any foods or beverages that contain alcohol, caffeine, and nicotine. Participants will be instructed to be well-rested and to avoid exercise for 24 hours prior to each visit. Water intake will be encouraged during this time for appropriate hydration status. Participants will then have their height, body mass, resting heart rate, blood pressure, and urine specific gravity measured prior to completing their body composition assessment (only study visit 1) using a bioelectrical impedance analyzer (BIA). This study visit and all subsequent study visits will be scheduled between 0600 - 1000 hours. This study visit is estimated to take about 45 minutes to complete. Visit 2-4 There is no required minimum time between Visit 1 and Visit 2. Visit 3 will occur 15 ± 3 days after Visit 2, 2 and Visit 4 will occur 28 ± 3 days after Visit 3. Participants will be required to follow identical pre-testing guidelines consisting of an overnight fast (8-10 hours) of food or drink with calories including any foods or beverages that contain alcohol, caffeine, and nicotine. Participants will be instructed to be well-rested and to avoid exercise for 24 hours prior to each visit. Water intake will be encouraged during this time for appropriate hydration status. Body mass, resting heart rate, and resting blood pressure will be measured. Female participants will take a urine pregnancy test to ensure they are not pregnant. Using standard phlebotomy approaches, approximately 21 mL of venous blood will be collected from a forearm vein. Participants will then complete the NIH Toolbox Cognitive Function Battery, NIH Toolbox Emotion Function Test, RAND SF-36 to assess well-being/mood, Stroop Color and Word test, Trail Making Test A and B, Finger tapping test, and the NIH Toolbox General Life Satisfaction score. After baseline testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a dietary supplement. They will consume their supplement at the end of visits 2 and 3. Supplement compliance will be assessed through daily logging by the participant and checked by research team members calculating remaining amount of supplement during study visits. ;
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