Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
- Conditions
- Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis
- Interventions
- Other: Plant-based fasting-mimicking diet
- Registration Number
- NCT05382897
- Lead Sponsor
- University of Alberta
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Age ≥ 18 and ≤ 65 years at the time of screening
- 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)
- Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fasting-Mimicking Diet Plant-based 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. Caloric-Sufficient Diet 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 clinical markers of disease From baseline through 12 and 24 weeks Changes in fecal calprotectin
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 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 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 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 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 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 weight From baseline through 12 and 24 weeks Changes in weight in kilograms
Changes in fecal bile acids From baseline through 12 and 24 weeks Changes in fecal concentrations of primary and secondary bile acids
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 fecal short chain fatty acids From baseline through 12 and 24 weeks Changes in fecal concentrations of short chain fatty acids
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
Trial Locations
- Locations (2)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alberta Human Nutrition Research Unit
🇨🇦Edmonton, Alberta, Canada