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| Name | Class |
|---|---|
| W. Garfield Weston Foundation | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting-Mimicking Diet | Experimental | 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. |
|
| Caloric-Sufficient Diet | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based fasting-mimicking diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | From baseline through 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline through 12 and 24 weeks |
| Changes in partial Mayo Score in patients with ulcerative colitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Madsen, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2E1 | Canada | ||
| University of Alberta Human Nutrition Research Unit |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D003863 | Depression |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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This is an exploratory randomized double-blind parallel trial using a fasting-mimicking diet (FMD) in patients with inflammatory bowel disease (IBD) who are in clinical remission but experiencing depression
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Investigator and lab personnel involved in assessment of outcomes will be blinded to the group allocation.
Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis |
| From baseline through 12 and 24 weeks |
| Changes in clinical markers of disease | Changes in serum C-reactive protein (CRP) | From baseline through 12 and 24 weeks |
| Changes in clinical markers of disease | Changes in fecal calprotectin | 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) | 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) | 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) | From baseline through 12 and 24 weeks |
| Changes in weight | Changes in weight in kilograms | 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 | 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 | 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) | From baseline through 12 and 24 weeks |
| Changes in blood hormones | Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin) | From baseline through 12 and 24 weeks |
| Changes in gut microbiome | Changes in gut microbiome as assessed by 16s rRNA analysis | From baseline through 12 and 24 weeks |
| Changes in fecal short chain fatty acids | Changes in fecal concentrations of short chain fatty acids | From baseline through 12 and 24 weeks |
| Changes in fecal bile acids | Changes in fecal concentrations of primary and secondary bile acids | From baseline through 12 and 24 weeks |
| Edmonton |
| Alberta |
| T6G 2E1 |
| Canada |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005247 | Feeding Behavior |