The DIET study: A randomized controlled trial of a high fiber diet intervention (HFDI) in patients (pts) with melanoma receiving immune checkpoint blockade (ICB)
Abstract
9558 Background: Multiple studies support that the gut microbiome plays a key role in response to ICB. Habitual high dietary fiber intake is associated with improved response to ICB and high fiber diet interventions have been shown to favorably modulate the microbiome in non-cancer populations. We therefore conducted a randomized trial of HFDI versus healthy control diet in melanoma pts receiving ICB. Methods: 45 melanoma pts starting ICB (21 adjuvant, 12 neoadjuvant, 12 advanced unresectable) were enrolled. Pts were randomized 2:1 to HFDI (30 to 50 g/day by ramp-up) or control (20 g) stratified by BMI and treatment (tx) intent. Inclusion criteria included BMI 18.5-40 kg/m2 and willing to exclusively eat the provided diet. Exclusion criteria include diabetes, major gastrointestinal disease/surgery, probiotic, antibiotic, or steroid use within 14 days, smoker or heavy drinker, and average dietary fiber intake > 20g/day. As a controlled feeding study, the weekly menu in both arms were isocaloric (matched to patient’s energy needs via 30% fat, 50% carbohydrates, 20% protein) and provided by MD Anderson Bionutrition Research Core for up to 11 weeks. Both diets followed cancer prevention recommendations with little to no processed meats or added sugars; no alcohol consumption; and dietary fiber intake scaled through whole, plant foods. Blood and stool samples were collected longitudinally. Compliance was defined by the proportion of calories consumed vs. provided. Results: 65 pts…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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