ArticlemedRxiv : the preprint server for health sciences2026
A Randomized Controlled Trial Comparing Soy-Pea Protein to Animal Protein in Adults with Crohn's Disease.
Article in medRxiv : the preprint server for health sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04065048 (A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients), which is not on this map. Not yet cited in PubMed.
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A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients
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13 authors.
Funding
Abstract
Background and Aims: Diet plays a critical role in managing Crohn's disease (CD) inflammation. We assessed whether dietary replacement of animal protein (AnimalP) by soy-pea protein (SoyP) decreases the pro-inflammatory potential of gut microbiota and intestinal inflammation in CD patients. Design: In an open-label, randomized controlled feeding trial at University Hospitals Cleveland Medical Center, CD participants and healthy controls were randomized (1:1) to a soy-pea or animal protein diet for 7-days. Primary outcomes were the absolute difference (Δd7-d0) in; Crohn's Disease Activity Index (CDAI) score and fecal myeloperoxidase (MPO). Secondary outcomes included fecal calprotectin (FC) and high-sensitivity C-reactive protein (hsCRP). Murine fecal transplantation experiments were performed to determine the inflammatory potential of diet-altered gut microbiota. Results: The study randomized 66 participants, of whom 60 were included in the final analysis (n=31 CD, n=29 HC). After 7 days, CD participants assigned to the SoyP diet were more likely than those assigned to the AnimalP diet to demonstrate reductions in fecal MPO (RR=2.30, 95% CI: 1.04-4.85, P=0.032) and HBI (RR=4.68, 95% CI: 1.22-17.98, P=0.009). The association between SoyP and reduced fecal MPO remained significant after Bonferroni adjustment (FWER-adjusted P=0.006). A similar directional trend was observed for CDAI (RR=1.52, 95% CI: 0.89-2.58, P=0.135), although this did not reach statistical significance. No participants experienced worsening of CDAI. The exploratory post hoc rank-based CDAI-MPO composite score was lower in the CD-SoyP versus CD-AnimalP group (median [IQR]: 5 [4-6] vs 8 [7-9]; P=0.012). Stratified analyses demonstrated significant reductions in fecal MPO among CD participants with lower baseline disease activity (CDAI <150; P<0.0001), but not among those with higher disease activity (P=0.799). Conclusion: Short-term addition of plant-based soy-pea protein within a controlled diet was associated with reductions in objective inflammatory markers in CD, with evidence of greater effects among participants with lower baseline disease activity. ClinicalTrials.gov, Number NCT04065048.
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