Clinical Trials Directory

Trials / Completed

CompletedNCT05382897

Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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

Conditions

Interventions

TypeNameDescription
OTHERPlant-based fasting-mimicking dietParticipants will be on a low caloric plant-based diet or a caloric-sufficient plant-based diet for 3 x 5 day cycle each month followed by 3 weeks of eating normally for a total period of 3 months.

Timeline

Start date
2022-07-01
Primary completion
2025-02-02
Completion
2025-02-02
First posted
2022-05-19
Last updated
2025-09-11

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT05382897. Inclusion in this directory is not an endorsement.