Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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:
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Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis
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Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting
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Examine effects of the intervention on the gut microbiome and metabolome
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fasting-Mimicking Diet 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 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.
|
| Experimental: Caloric-Sufficient 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.
|
Outcome Measures
Primary Outcome Measures
- Changes in Patient Health Questionnaire (PHQ-9) [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]
Secondary Outcome Measures
- Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease [From baseline through 12 and 24 weeks]
Changes in disease status as assessed by HBI in Crohn's disease patients
- Changes in partial Mayo Score in patients with ulcerative colitis [From baseline through 12 and 24 weeks]
Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis
- Changes in clinical markers of disease [From baseline through 12 and 24 weeks]
Changes in serum C-reactive protein (CRP)
- Changes in clinical markers of disease [From baseline through 12 and 24 weeks]
Changes in fecal calprotectin
- Changes in levels of fatigue [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)
- Changes in general anxiety [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)
- Changes in quality of Life [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)
- Changes in weight [From baseline through 12 and 24 weeks]
Changes in weight in kilograms
- Changes in body mass index (BMI) [From baseline through 12 and 24 weeks]
Changes in BMI as assessed by weight in kilograms divided by the square of height in meters
- Changes in gene expression in peripheral blood mononuclear cells [From baseline through 12 and 24 weeks]
Changes in immune function as assessed by changes in gene expression of peripheral blood mononuclear cells
- Changes in blood cytokines [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)
- Changes in blood hormones [From baseline through 12 and 24 weeks]
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
- Changes in gut microbiome [From baseline through 12 and 24 weeks]
Changes in gut microbiome as assessed by 16s rRNA analysis
- Changes in fecal short chain fatty acids [From baseline through 12 and 24 weeks]
Changes in fecal concentrations of short chain fatty acids
- Changes in fecal bile acids [From baseline through 12 and 24 weeks]
Changes in fecal concentrations of primary and secondary bile acids
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 and ≤ 65 years at the time of screening
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Diagnosis of Crohn's disease in clinical remission with Harvey Bradshaw Index (HBI<5) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo<2)
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Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19
Exclusion Criteria:
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Subjects who are reliant on partial or total parenteral nutrition
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Subjects with prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, or ileoanal pouch
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Subjects with diabetes or celiac disease
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Subjects with a body mass index (BMI) lower than 18
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Subjects suffering from malnutrition or at high risk of malnutrition assessed by a score of ≥6 on the abridged patient generated subjective global assessment (PGSGA)
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Subjects allergic to nuts
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Subjects currently on a fasting/intermittent type caloric restricted diet
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History of psychotic or bipolar disorders or experiencing suicidal thoughts
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Pregnant women, women who are breast feeding, or women planning on becoming pregnant
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Subjects with immune-compromised condition other than inflammatory bowel disease (e.g. AIDS, lymphoma)
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Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy
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Unable to read English or provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2E1 |
| 2 | University of Alberta Human Nutrition Research Unit | Edmonton | Alberta | Canada | T6G 2E1 |
Sponsors and Collaborators
- University of Alberta
- W. Garfield Weston Foundation
Investigators
- Principal Investigator: Karen Madsen, PhD, University of Alberta
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Pro00115405