A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
Condition: Cognitive Impairment; Cognitive Decline; Cognition Disorders in Old Age; Well-Being, Psychological; Inflammation; Cognitive Fun
MeSH terms: Inflammation; Cognitive Dysfunction; Cognition Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): LasoperinTM; Placeo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; Active ingredients:
N/A
Inactive ingredients:
Microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel design
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: cognitive function; inflammation; well being