Abstract
Diet may influence ulcerative colitis (UC), but its impact on medication response remains unclear. We examined whether two 5-day cycles of a low-calorie, plant-based fasting-mimicking diet (LC-PB) could improve UC response to medications in a controlled trial.
Adults with active UC starting advanced therapies were randomized to LC-PB + therapy or control diet + therapy. The LC-PB diet provided 1,090 kcal on day one and 725 kcal on days 2-5. SCCAI was assessed at baseline and week 8. The study, planned for 60 patients, ended early due to COVID-19. The primary endpoint was clinical response (week 8, SCCAI decrease ≥ 3). Secondary outcomes were clinical improvement (change in SCCAI from baseline), steroid tapering, C-reactive protein (CRP), serum amyloid A (SAA), and FC (FC).
Of 32 enrolled patients, 23 completed the study. In ITT, 57% in the LC-PB arm (8/14) achieved clinical response by week 8 vs. 35% in controls (6/17, p = 0.11). Secondary analyses indicated greater clinical improvement, measured as continuous SCCAI, in the LC-PB compared to control group (p = .039). The LC-PB group had better SCCAI sub-scores (i.e. urgency, well-being), reductions in SAA and were tapered off steroids compared to controls. Mean CRP and FC decreased more on the LC-PB, but results were not significant. There were no serious adverse events relating to the diet and no weight loss.
The LC-PB diet did not improve clinical response to medications. However, it led to clinical improvement, steroid tapering, and reduced SAA. As results were limited by sample size, larger studies are needed.