NCT05536544

The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program

The Inflammatory Bowel Disease Mediterranean Diet (IBDMED) Microbiome-targeting Nutritional Education Program for CD Control and Prevention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The rising incidence of Crohn's disease (CD) and ulcerative colitis (UC), especially in the newly industrialized nations of Asia, highlights the possible role of environmental triggers such as diet and the gut microbiome in the pathogenesis of inflammatory bowel diseases (IBD). The Mediterranean diet (MED) has been previously correlated with beneficial outcomes in several chronic and immune-mediated diseases and has been linked with positive outcomes in IBD. However, consumption of high fiber foods like fruits, vegetables, whole grains, legumes and nuts may be challenging for patients with IBD without tight dietary guidance and support. The IBDMED nutritional education program aims to improve the adherence of patients with IBD to MED. Patients are educated on how to implement and incorporate MED principles into their daily lifestyle, by providing information, tips, practical tools, cooking methods and recipes, that are available on an interactive website and application. Patients are monitored for their diet, sleep, physical activity and stress levels via fitness trackers and questionnaires developed for this study and receive feedback and personal recommendations from the study dietitians along the way. This RCT will assess the feasibility and effects of an 8-week IBDMED nutritional and lifestyle education program vs. the nutritional standard of care in patients with newly diagnosed CD and in healthy subjects in Israel and India.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	IBDMED	The IBDMED program will be applied for 8 weeks and include education on MED diet and lifestyle components, focused on increasing and diversifying dietary fiber intake, reduction of ultra-processed food intake and promoting an active lifestyle. This intervention is digitally supported by an interactive website application and step trackers to monitor lifestyle parameters.
OTHER	Control	Dietary counseling according to the local dietary guidelines for patients with IBD

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-05-01
• Completion: 2024-12-01
• First posted: 2022-09-13
• Last updated: 2022-09-13

Locations

2 sites across 2 countries: India, Israel