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

Completed · Not applicable · Has a placebo group

Conditions studied: Cognitive Impairment, Cognitive Decline, Cognition Disorders in Old Age, Well-Being, Psychological, Inflammation, Cognitive Fun

In brief

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.

Key facts

Study ID: NCT05994391
Run by: Lindenwood University
People needed: 100
Starts: 2022-06-03
Expected to finish: 2022-10-18
Last updated by the study team: 2023-08-16

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

1. Participants who are lactating, pregnant or planning to become pregnant during the study.
Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
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).
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.
Major surgery in 3 months prior to screening or planned major surgery during the course of the study.
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).
Participant has a history of alcohol or substance abuse in the 12 months prior to screening.
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.
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.

Where it is running

Exercise and Performance Nutrition Laboratory — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

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