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

Summary

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.

Conditions

• Crohn Disease

Interventions

OTHER

Therapeutic diet Intervention

The CD-TDI will incorporate global principles of the Mediterranean Diet (MD) refined to inform specific food choices based on our pilot data results and published literature reported mechanisms of mitigating inflammation in IBD. Patient compliance will be measured in three ways: 1) Mediterranean diet score checklists completed every 3 weeks at the face-to-face visits; 2) goal attainment scores captured weekly to identify the goals set, and the goals attained 47; and 3) fatty acids profiled from red blood cells to identify if fat intake reflects CD-TDI fat recommendations: 35% total calories from fat, 15% from MUFA, 13% from SFA and 6% from PUFA with a 8 n6:n:3 ratio of 8:1

Sponsors & Collaborators

• Crohn's and Colitis Foundation

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• University of Guelph

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Alphabiomics

  collaborator UNKNOWN

• University of Birmingham

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Maitreyi Raman, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-20

Primary Completion

2023-02-12

Completion

2023-06-12

Countries

• Canada

Study Locations