Table 1.

Objectives and outcomes

Objectives Assessment of:	Measures	Method of assessment
1. Safety and tolerability	i. RBC, WBC, platelets ii. eGFR, electrolytes, BUN:Cr, AST, ALT, GGT, alkaline phosphatase, bilirubin iii. Heart rate, blood pressure, temperature, body mass index (BMI) iv. Adverse events and quality of life	i. Complete blood count (CBC) ii. Comprehensive metabolic panel (CMP) iii. Vital sign measurement iv. Adverse event monitoring and PROMIS-29 questionnaire
2. Disease activity	i. Clinical activity	i. Crohn’s Disease Activity Index (CDAI)
3. Inflammation	i. Inflammatory cytokines ii. Fecal calprotectin	i. Serum or plasma analysis ii. Fecal analysis
4. Gut permeability and endotoxemia	i. CD14, lipopolysaccharide (LPS) and LPS-binding protein, intestinal fatty acid binding protein	i. Plasma analysis
5. Platelet function	i. Platelet signaling, secretion, and procoagulant activity	i. Proteomic analysis ii. Flow cytometry
6. Microbiome and bile acid compositions	i. Metagenomic DNA sequencing and taxonomic profiling ii. Proteomic characterization iv. Bile acid profiling	i. Stool analysis ii. Activity-based proteomic assay iii. Plasma analysis
7. Metabolic profile of XN	iv. Xanthohumol (XN), isoxanthohumol, 6-prenylnaringenin, 8-prenylnaringenin, desmethylxanthohumol (DXN), dihydro-desmethylxanthohumol (DDXN)	iv. 24-h urinalysis, plasma analysis, stool analyses