Plant-based fasting-mimicking diet
OtherParticipants 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.
NCT Number: NCT05382897
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
University of Alberta Hospital, Edmonton, Alberta, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From baseline through 12 and 24 weeks
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 disease status as assessed by HBI in Crohn's disease patients
Time frame: From baseline through 12 and 24 weeks
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 serum C-reactive protein (CRP)
Time frame: From baseline through 12 and 24 weeks
Changes in fecal calprotectin
Time frame: From baseline through 12 and 24 weeks
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 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 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 in kilograms
Time frame: From baseline through 12 and 24 weeks
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 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 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 plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
Time frame: From baseline through 12 and 24 weeks
Changes in gut microbiome as assessed by 16s rRNA analysis
Time frame: From baseline through 12 and 24 weeks
Changes in fecal concentrations of short chain fatty acids
Time frame: From baseline through 12 and 24 weeks
Changes in fecal concentrations of primary and secondary bile acids
University of Alberta
Other
Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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