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Clinical Trial Summary

Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.


Clinical Trial Description

The primary objective of this proof of principle study is to investigate the effects of a fasting mimicking diet on depressive symptoms in patients with inflammatory bowel disease. The specific aims of this project include: 1. Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis 2. Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting 3. Examine effects of the intervention on the gut microbiome and metabolome ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05382897
Study type Interventional
Source University of Alberta
Contact Karen Madsen, PhD
Phone 78045925257
Email karen.madsen@ualberta.ca
Status Recruiting
Phase Early Phase 1
Start date July 1, 2022
Completion date December 2024

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