Evaluating protein SUPPLEMENTation in Ulcerative Colitis (SUPPLEMENT-UC)
This is the first ever study to investigate whether animal-based protein supplements influence the ability of adults with quiescent UC to maintain remission, and to explore the mechanistic basis and relationship between dietary substrate, gut microbiota, and disease activity.
Abstract
A higher dietary protein intake has overall health and body composition benefits but also has the propensity to drive inflammation in ulcerative colitis (UC). This study aims to investigate whether recreational animal-based protein supplementation affects ability to maintain remission in adults with clinically quiescent UC. Twenty-four adults with quiescent UC (Simple Clinical Colitis Activity Index (SCCAI) ≤2) on stable therapy will be randomised to a 24-week double blind, parallel, placebo-controlled protein supplement intervention in addition to habitual diet. The primary outcome is maintenance of remission (defined as SCCAI ≤2) at 24 weeks, relapse being defined as an increase in SCCAI ≥2 points and/or escalation of medical therapy. Disease activity will be assessed using clinical, biochemical and sonographic indices. Adherence, tolerability and safety will be measured using pre-defined categories and 100-mm visual analogue scales. Dietary intake and change in body composition will be measured along with biomarkers and metabolites of fermentation in faecal, blood and urine specimens. This trial addresses one of the top three international IBD research priorities - the role of diet to induce/maintain remission in UC. It will be the first ever study to investigate whether animal-based protein supplements influence the ability of adults with quiescent UC to maintain remission, and to explore the mechanistic basis and relationship between dietary substrate, gut microbiota, and disease activity. The trial results are anticipated to inform UC treatment paradigms by demonstrating dietary factors influence disease activity and dietary advice can be readily incorporated into current UC treatment paradigms as a cost neutral, adjunctive therapy to optimise response to existing therapies. The ultimate goal is to optimise therapeutic outcomes and improve quality of life for people with UC.