Table 2.

Aims and methods of assessment

Aim	Marker	Assessment method
1. Safety & Tolerability	a. RBC, WBC, platelets b. eGFR, electrolytes, BUN:Cr, AST, ALT, GGT, alkaline phosphatase, bilirubin c. Adverse events, quality of life	a. Complete Blood Count (CBC) b. Comprehensive Metabolic Panel (CMP) c. Adverse Events Questionnaire, PROMIS-29
2. Inflammation	a. Inflammatory cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, TNF-α, and IL-12p70 b. Fecal calprotectin	a. Serum or plasma analysis b. Stool analysis
3a. Gut Permeability	a. CD14, lipopolysaccharide binding protein, intestinal fatty acid binding protein	a. Plasma analysis
3b. Xanthohumol Metabolism	a. Xanthohumol metabolite profiles	a. 24-hour urinalysis, plasma analysis, stool analysis
3c. Microbial Composition Changes	a. Metagenomic DNA sequencing and taxonomic profiling b. Proteomic characterization	a. Compared to xanthohumol metabolite profiles b. Activity-based proteomic assay