Safety Evaluation of THC-Free Hemp Protein Isolate

To determine whether THC-COOH, the primary metabolite of THC, is detectable in participants' urine after 30 days of consuming 40 grams of Agoge Hemp Protein Powder.

A 'clinically-significant laboratory abnormality' is defined as any value judged by the principal investigator to be new-onset or ≥ 1 severity grade and rated as at least 'possibly related' to the study product, using CTCAE v5.0 grading where available. CBC - hemoglobin, hematocrit, WBC, or platelet count that shifts from normal at baseline to below/above reference limits by ≥ 1 CTCAE grade. Hepatic Panel - AST or ALT rises to > 2 x upper limit of normal (ULN). Renal Panel - estimated glomerular filtration rate (eGFR) falls to < 60 mL/min/1.73 m^2 or decreases by ≥ 25% from baseline; blood-urea-nitrogen-to-creatinine ratio (BUN:Cr) rises above 20:1 if previously normal. Venous blood is drawn at day 0 and day 30 for CBC, CMP, and calculated eGFR. Results are entered into REDCap, reviewed by a clinician, and coded for relatedness and severity. The study will report n/N (%) of participants meeting any abnormality criterion.

Any self-reported adverse event (AE) deemed at least "possibly related" to the study product. Data collection will occur through a 7-item symptom questionnaire through a REDCap Survey querying about nausea, headache, dizziness, fatigue, skin reactions, gastrointestinal issues, or any other unsolicited symptoms. If any symptom is reported, study staff complete a standardized spontaneous AE reporting form. Each AE is graded for severity (mild, moderate, severe) and relatedness (unrelated, possibly, probably, or definitely) by study staff. The count and proportion of participants experiencing ≥ product-related AE over the 30-day intervention will be reported (n/N [%])