NCT04596566: TDI

Modeling Patient Response to a Therapeutic Diet in Crohn's Disease

Status unknown NA Last updated 22 October 2020

What this trial tests

NA trial testing Therapeutic diet Intervention in Crohn Disease in 102 participants. Status unknown.

Timeline

20 February 2020

Primary endpoint
12 February 2023

12 June 2023

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	102
Start date	20 February 2020
Primary completion	12 February 2023
Estimated completion	12 June 2023
Sites	1 location across Canada

Drugs / interventions tested

• Therapeutic diet Intervention

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BACKGROUND: There is an urgent need to understand the role of therapeutic dietary interventions on the treatment of inflammatory bowel disease (IBD). Although nutritional observational studies have examined associations between diet and the development of IBD, the relationship between dietary components and disease relapse is lacking. Despite the lack of a well-defined relationship between dietary determinants and disease relapse, patients with IBD frequently have a strong belief that diet has a key role in controlling the course of their disease, and maybe a trigger of disease relapse. This proposed randomized controlled trial (RCT) explores the efficacy of a Crohn's Disease (CD) Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate luminal CD. For asymptomatic patients with active disease, efficacy of the diet will be explored by using fecal calprotectin and sonographic findings

Rationale: Our team of investigators recently compared a representative healthy population to patients with CD and identified CD patients have: lower intakes of polyunsaturated and monounsaturated fats and multiple micronutrients (vitamins C, D, thiamine magnesium, phosphorus, zinc, potassium), and; few patients with CD met criteria for an anti-inflammatory dietary pattern. Since the diet is a modifiable potential risk factor for disease recurrence in IBD, there is a strong rationale for the investigation of diet on disease course. Additionally, patients have expressed strong interest in identifying the relationships between diet and disease, therefore assigning priority to this theme is an opportunity to advance patient-oriented care.

Publications & conference data

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

1. Crohn's disease therapeutic dietary intervention (CD-TDI): study protocol for a randomised controlled trial.
   Raman M, Ma C, Taylor LM, Dieleman LA, et al · · 2022 · cited 3× · PMID 35046093 · DOI 10.1136/bmjgast-2021-000841
2. Exploring the connection between erythrocyte membrane fatty acid composition and oxidative stress in patients undergoing the Crohn's disease Therapeutic Diet Intervention (CD-TDI).
   Haskey N, Letef C, Sousa JA, Yousuf M, et al · · 2025 · cited 2× · PMID 39963251 · DOI 10.1177/17562848251314827
3. Beyond Nutrients: NOVA-Defined Dietary Patterns in Crohn's Disease and Healthy Adults.
   Lewis A, Ulsamer T, Franco L, Gold S, et al · · 2026 · PMID 41978118 · DOI 10.3390/nu18071068