NCT04046913

The ADDapt Diet in Reducing Crohn's Disease Inflammation

Status unknown NA Last updated 6 June 2024

What this trial tests

NA trial testing Dietary education in Crohn Disease in 154 participants. Status unknown.

Timeline

9 September 2019

Primary endpoint
25 April 2024

20 August 2024

Quick facts

Lead sponsor	King's College London
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	154
Start date	9 September 2019
Primary completion	25 April 2024
Estimated completion	20 August 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• Dietary education

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →

Sponsor

King's College London

Who can join

16 and older, any sex, with Crohn Disease or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
   Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z
2. The Future of Food Processing-A Food Science and Technology Perspective. Proceedings of a Roundtable Event.
   Lockyer S, Forde C, Adams M, Edwards C, et al · · 2026 · PMID 41531017 · DOI 10.1111/nbu.70043
3. Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.
   Noor NM, Siegel CA. · · 2023 · PMID 37772152