An interventional study of Plant-based fasting-mimicking diet in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by University of Alberta. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
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:
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be followed for 3 weeks for baseline assessment and then consume a plant-based fasting-mimicking diet for 5 days once a month for 3 months.
Other: Plant-based fasting-mimicking diet
Participants will be followed for 3 weeks for baseline assessment and then consume a plant-based caloric-sufficient diet for 5 days once a month for 3 months.
Other: Plant-based fasting-mimicking diet
Participants 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.
Changes in Patient Health Questionnaire (PHQ-9)
A change in depressive symptoms as assessed through the Patient Health Questionnaire (PHQ)-9. \[Min:0; Max 27; good to poor\]
Time frame: From baseline through 12 and 24 weeks
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Changes in disease status as assessed by HBI in Crohn's disease patients
Time frame: From baseline through 12 and 24 weeks
Changes in partial Mayo Score in patients with ulcerative colitis
Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis
Time frame: From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Changes in serum C-reactive protein (CRP)
Time frame: From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Changes in fecal calprotectin
Time frame: From baseline through 12 and 24 weeks
Changes in levels of fatigue
Changes in level of fatigue as assessed by the inflammatory bowel disease-fatigue (IBD-F) self-assessment scale (0-20; low to high)
Time frame: From baseline through 12 and 24 weeks
Changes in general anxiety
Changes in general anxiety as assessed by the Hospital Anxiety and Depression scale (HADS) (0-21; low to high)
Time frame: From baseline through 12 and 24 weeks
Changes in quality of Life
Changes in quality of life as assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (score 10-70, poor to good)
Time frame: From baseline through 12 and 24 weeks
Changes in weight
Changes in weight in kilograms
Time frame: From baseline through 12 and 24 weeks
Changes in body mass index (BMI)
Changes in BMI as assessed by weight in kilograms divided by the square of height in meters
Time frame: From baseline through 12 and 24 weeks
Changes in gene expression in peripheral blood mononuclear cells
Changes in immune function as assessed by changes in gene expression of peripheral blood mononuclear cells
Time frame: From baseline through 12 and 24 weeks
Changes in blood cytokines
Changes in plasma concentrations of cytokines (TNF, IL-6, IL-8, IFNγ, IL-1β, IL-9, IL-10, IL-12, IL-17, TGFβ)
Time frame: From baseline through 12 and 24 weeks
Changes in blood hormones
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
Time frame: From baseline through 12 and 24 weeks
Changes in gut microbiome
Changes in gut microbiome as assessed by 16s rRNA analysis
Time frame: From baseline through 12 and 24 weeks
Changes in fecal short chain fatty acids
Changes in fecal concentrations of short chain fatty acids
Time frame: From baseline through 12 and 24 weeks
Changes in fecal bile acids
Changes in fecal concentrations of primary and secondary bile acids
Time frame: From baseline through 12 and 24 weeks
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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University of Alberta