Academics

A Randomized
Double-Blind Prospective Evaluation of the Cognitive Impacts of a Dietary Supplement in Healthy Adults

A Randomized
Double-Blind Prospective Evaluation of the Cognitive Impacts of a Dietary Supplement in Healthy Adults

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LU IRB#: IRB-22-78
PI: Chad Kerksick, PhD

Description of Study

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.

Location
Exercise and Performance Nutrition Laboratory (Fieldhouse 126)
209 S. Kingshighway
St. Charles, MO 63301

Number of Visits
4

Time Commitment
Visits 1: 45 Minutes
Visits 2-4: 90 Minutes Each

Compensation
$200 (Direct Deposit)
$50 Referral Bonus

Point of Contact
Joesi Krieger and Anthony Hagele
epnl@lindenwood.edu

Research Sample Needed

  • 100 healthy men and women

Inclusion Criteria

  • Healthy adult participants who are 30 to 60 years of age.
  • 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.
  • Have normal or acceptable vital signs (blood pressure and heart rate) at screening and/or baseline
  • Individuals with childbearing potential must agree that they and/or their partner will practice birth control upon enrollment and throughout the study (abstinence, tubal ligation, vasectomy, progestin arm implant, intrauterine device, oral contraceptives, progestin injection, emergency contraception, male condoms, diaphragm, cervical cap, female condom, sponge, withdrawal method, spermicides, rhythm tracking, etc.)
  • 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 Criteria

  • Childbearing participants who are lactating, currently pregnant or 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 will be terminated if receiving the COVID-19 vaccination during the study trial
  • Participants with diagnosed type I or type II diabetes.
  • Having a history of heart disease, uncontrolled high blood pressure (≥140 mmHg systolic or ≥90 mmHg diastolic), renal or hepatic impairment/disease or dysfunction, major affective disorders, 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. Outside of these highlighted outcomes, study participants can be excluded based upon an evaluation by research staff and consultation with the medical director if the presence of any medical condition or disorder 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 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, over the previous 12 months, has a history of regular alcohol use that exceeds more than 2 standard alcoholic drinks per day or more than 10 drinks per week 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.

Are You Eligible?

Information provided here reflects current IRB approval for this research. However, this information may be subject to change and updated accordingly.