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Table 2 BRIDGE-CRC trial measurements

From: Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity

Data type

Baseline

Month 3

Month 6

Anthropometrics

 Height

X

  

 Weighta

X

X

X

 Body composition (DXA)

X

 

X

Inflammatory markers

 Systemic inflammation (hs-CRP)

X

X

X

 Circulating cytokines (GM-CSF, IL-2, IL-4, IL-6, IL-8, IL-10, TNFα, and IFNγ)

X

X

X

Metabolic risk

 Glucose, mg/dL

X

X

X

 Insulin, uIU/mL

X

X

X

 Hemoglobin A1c, %

X

X

X

 HOMA-IR (calculated from glucose and insulin)

X

X

X

Blood pressure, mmHg

X

 

X

Dietary intake

 VioScreen food frequency questionnaire (FFQ)

X

 

X

 24-h diet recall (two per timepoint) (ASA24)

X

X

X

 MEPA-III MedDiet screener

X

X

X

Medication use

X

X

X

Physical activity (steps per day, FitBit)

X

 

X

Microbiota composition (16S rRNA)

X

X

X

Predicted gene abundance, metabolic pathways, and microbial network analysis

X

X

X

Quantification of the following genes via PCR: dissimilatory sulfite reductase A (pandsrA), B. wadsworthia-specific dsrA, 16S rRNA, Desulfovibrio spp.-specific 16S rRNA, BA 7α-dehydratase from C. scindens, butyryl-CoA transferase gene (BcoA)

X

X

X

Fecal short chain fatty acids (uM) (e.g., butyrate, acetate, and propionate)

X

X

X

Fecal and circulating bile acids (uM) (i.e., total BAs, total unconjugated BAs, taurine- and glycine-conjugated BAs, and CA, CDCA, LCA, and DCA)

X

X

X

Exfoliated intestinal cell gene expression analysis

X

X

X

Surveys

 Demographics

X

  

 Health history, including bowel health

X

 

X

 Sleep quality

X

 

X

 Food away from home

X

 

X

 Psychosocial variables

  Discrimination

X

  

  Food security

X

 

X

  Depressive symptoms

X

 

X

  Stress

X

 

X

  Recent trauma

X

 

X

  Anxiety

X

 

X

  1. Abbreviations: BA bile acid, CA cholic acid, CDCA chenodeoxycholic acid, DCA deoxycholic acid, DXA dual energy X-ray absorptiometry, GM-CSF granulocyte-macrophage colony-stimulating factor, HOMA-IR Homeostatic Model Assessment for Insulin Resistance, hs-CRP high-sensitivity C-reactive protein, IFN interferon, IL interleukin, LCA lithocholic acid, MedDiet Mediterranean diet, MEPA Mediterranean Eating Pattern for Americans, TNF tumor necrosis factor
  2. aWeight will also be recorded as needed throughout the intervention to monitor compliance