Clinical trial NCT05994391: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Cognitive Decline
Cognition Disorders in Old Age
Well-Being, Psychological
Inflammation
Cognitive Fun
Keywords: cognitive function
inflammation
well being
Lead sponsor: Lindenwood University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel design
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult participants who are 30 to 60 years of age (inclusive).
2. In good general health (no active or uncontrolled diseases or conditions).
3. Have a body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive).
4. Have normal or acceptable to the investigator vital signs (blood pressure and heart rate) at screening and/or baseline.
5. 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:

   1. 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
   2. 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
   3. 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.
6. Agree to refrain from treatments listed in Section 6.4 in the defined timeframe.
7. Willing to refrain from changing their diet or lifestyle significantly for the duration of the study.
8. 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.

Primary outcomes:
measure: NIH Toolbox Cognitive Testing - Flanker Inhibitory Control
timeFrame: 30 days
measure: NIH Toolbox Cognitive Testing - dimensional change card sort test
timeFrame: 30 days
measure: NIH Toolbox Cognitive Testing - Pattern Comparison Processing Speed Test
timeFrame: 30 days
measure: NIH Toolbox General Life Satisfaction Questionnaire
timeFrame: 30 days
measure: RAND SF-36 Questionnaire
timeFrame: 30 days
measure: Stroop Color Test
timeFrame: 30 days
measure: Trail Making Test Parts A & B
timeFrame: 30 days
measure: Finger Tapping Test
timeFrame: 30 days
Secondary outcomes:
measure: Blood Collection - C-Reactive Protein (CRP)
timeFrame: 30 days
measure: Blood Collection - Cortisol
timeFrame: 30 days
measure: Blood Collection - Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 30 days
measure: Blood Collection - Uric Acid
timeFrame: 30 days
measure: Resting Heart Rate
timeFrame: 30 days
measure: Resting Blood Pressure
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
References: