NCT04046913

The ADDapt Diet in Reducing Crohn's Disease Inflammation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalence of CD is 10.6 per 100,000 people in the UK and represents a significant annual financial burden of around €16.7 billion in Europe. A wide range of nutrients and food components have been investigated for their role in the pathogenesis and course of CD. A common theme suggests that CD risk is associated with a "Western diet", including high fat, high sugar and processed foods. However, intervention studies that exclude specific aspects of the diet such as sugar or that compare low and high fat diets have failed to show effectiveness in practice. Observational human and experimental animal studies suggest that certain food additives used extensively by the food industry play a role in the pathogenesis and natural history of CD. However, to date no evidence exists for the effectiveness of a diet low in these food additives in CD. Therefore, the aim of this study is to investigate the effects of a diet low in certain food additives compared to a normal UK diet on CD activity, health-related quality of life, gut bacteria, gut permeability, gut inflammation and dietary intake, in patients with mildly active, stable CD. We will recruit patients with mildly active CD and will randomise them to receive either the diet low in the food additives of interest, or the diet representative of a normal UK diet. Patients will follow their allocation diet for 8 weeks and will attend study visits at the start and end of the trial, at which points questionnaires will be completed and samples will be collected.

Conditions

• Crohn Disease
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Dietary education	Intervention: Low food additive diet. Control: Habitual food additive diet

Timeline

• Start date: 2019-09-09
• Primary completion: 2024-04-25
• Completion: 2024-08-20
• First posted: 2019-08-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: United Kingdom