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Be Part of Research - Trial Details - The ADDapt Diet in Reducing Crohn's Disease Inflammation

The ADDapt Diet in Reducing Crohn's Disease Inflammation

Not Recruiting

Open to: ALL

Age: 16.0 - N/A

Medical Conditions

Crohn Disease
Inflammatory Bowel Diseases
Inflammation


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2019 Apr 2024

INTERVENTIONAL

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

Intervention Arm Group : Habitual food additive diet;Low food additive diet;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College London
    London
    SE1 9HN


The study is sponsored by King's College London and is in collaboration with The Leona M. and Harry B. Helmsley Charitable Trust; Guy's and St Thomas' NHS Foundation Trust; Institut Pasteur.




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Read full details for Trial ID: NCT04046913
Last updated 05 June 2024

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