None (Healthy adults)
Conditions
Interventions
Single Intakes of test capsule
Single Intakes of test capsule
Sponsors
Kirin Holdings Company, Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Provide voluntary signed and dated informed consent. Be in good health and able to participate in cognitive performance testing as determined by medical history and routine blood chemistries. Between 18 and 35 years of age (inclusive). Body Mass Index of 18.5-31.9 (inclusive). Body weight of at least 120 pounds. Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. Normal supine, resting heart rate (<90 per minute). Agrees to maintain their existing dietary and physical activity patterns throughout the study period. If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study. Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hours, refrain from alcohol and exercise for 24 hours prior to each trial, and fast for 10 hours prior to each visit.
Exclusion criteria
Exclusion criteria: Smokes more than 10 cigarettes per day or uses other nicotine products (i.e., cigars, vape, patches, gum, etc) that deliver a similar amount of nicotine. Current use of any nootropic dietary supplements (e.g., Ginkgo biloba, L-theanine, choline, Lion's mane, creatine, etc.) or medications (e.g., piracetam, Adderall, modafinil, etc.) that may confound the study or its endpoints. Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease. Other known gastrointestinal or metabolic diseases that might impact nutrient absorption, distribution, metabolism, or excretion (e.g., intestinal malabsorption, electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism, etc.). Chronic medically diagnosed inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV-AIDS, etc.). Medical history of a cognitive (i.e., ADD-ADHD) or psychiatric disorder. Currently using medications to treat anxiety or depression. Have an irregular sleep pattern (i.e., shift workers) or inadequate sleep schedule (i.e., less than 6 hours per night). Known sensitivity, allergy, or intolerability to any ingredient in the test products. Individuals who are cognitively impaired and/or who are unable to give informed consent. Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate. t at increased risk of harm if they were to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective questionnaires using Visual Analog Scale (VAS) for emotional states, Cognitive function, Brain activation via Electroencephalography (EEG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive side effect profile- Confirmation of medical history during study period Adverse event monitoring- Occurrence of adverse events | — |
Countries
North America
Contacts
Public ContactJennifer Sandrock
The Center for Applied Health Sciences Chief Operating Officer
Outcome results
None listed