Status:
COMPLETED
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of LasoperinTM on Cognitive Function in Healthy Adults
Lead Sponsor:
Lindenwood University
Conditions:
Cognitive Impairment
Cognitive Decline
Eligibility:
All Genders
30-60 years
Phase:
NA
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 t...
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 interferen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05994391
Start Date
June 3 2022
End Date
October 18 2022
Last Update
August 16 2023
Active Locations (1)
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1
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, United States, 63301