Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
depression, diet, microbiome, fasting, inflammatory bowel disease
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.
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
Interventions
OTHERPlant-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.
Sponsors
W. Garfield Weston Foundation
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigator and lab personnel involved in assessment of outcomes will be blinded to the group allocation.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 65 years at the time of screening * Diagnosis of Crohn's disease in clinical remission or with mild-moderate disease with Harvey Bradshaw Index (HBI\<8) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo\<7) * Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19
Exclusion criteria
* Subjects who are reliant on partial or total parenteral nutrition * Subjects with prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, or ileoanal pouch * Subjects with diabetes or celiac disease * Subjects with a body mass index (BMI) lower than 18 * 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) * Subjects allergic to nuts * Subjects currently on a fasting/intermittent type caloric restricted diet * History of psychotic or bipolar disorders or experiencing suicidal thoughts * Pregnant women, women who are breast feeding, or women planning on becoming pregnant * Subjects with immune-compromised condition other than inflammatory bowel disease (e.g. AIDS, lymphoma) * Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy * Unable to read English or provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 |
Countries
Canada
Outcome results
None listed