A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults

NCT ID: NCT05994391

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-03
• Study Completion Date: 2022-10-18

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.

Conditions

Cognitive Impairment; Cognitive Decline; Cognition Disorders in Old Age; Well-Being, Psychological; Inflammation; Cognitive Fun

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

LasoperinTM

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

Group Type: EXPERIMENTAL

LasoperinTM

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placeo

Intervention Type: DIETARY_SUPPLEMENT

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline cellulose

Interventions

LasoperinTM

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

Intervention Type: DIETARY_SUPPLEMENT

Placeo

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lindenwood University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

IRB-22-78

Identifier Type: -

Identifier Source: org_study_id