Using a fasting-mimicking diet to treat depression in patients with inflammatory bowel disease

Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease

This study is testing if a special diet that mimics fasting can help improve depression in people with inflammatory bowel disease like Crohn's or ulcerative colitis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 2 sites (Edmonton, Alberta and 1 other locations)
• Trial ID: NCT05382897 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a fasting-mimicking diet on depressive symptoms in patients with inflammatory bowel disease (IBD), specifically those with Crohn's disease or ulcerative colitis. Participants will undergo three cycles of a 5-day plant-based low-caloric diet followed by three weeks of normal eating. The study aims to assess the impact of this dietary intervention on gut microbiome, immune and metabolic function, and depressive symptoms. The ultimate goal is to develop a safe and effective treatment to enhance mental health in IBD patients through dietary changes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with Crohn's disease or ulcerative colitis in clinical remission and experiencing mild to moderate depressive symptoms.

Not a fit: Patients with severe gastrointestinal issues, diabetes, or those on specific diets may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mental health and quality of life for patients suffering from depression related to inflammatory bowel disease.

How similar studies have performed: While the specific approach of a fasting-mimicking diet in this context is novel, there is emerging evidence supporting dietary interventions for mental health in similar patient populations.

Eligibility criteria

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

Where this trial is running

Edmonton, Alberta and 1 other locations

• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• University of Alberta Human Nutrition Research Unit — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Karen Madsen, PhD — University of Alberta
• Study coordinator: Karen Madsen, PhD

Conditions Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; depression; diet; microbiome; fasting; inflammatory bowel disease