NCT05382897Completed
Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 31 Jan 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 2 Feb 2025
- Lead sponsor
- University of Alberta
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05382897
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 1 Jul 2022 to the primary completion date, 2 Feb 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 currently on a fasting/intermittent type caloric restricted diet
Other illness
- Subjects with diabetes or celiac disease
- Subjects allergic to nuts
- History of psychotic or bipolar disorders or experiencing suicidal thoughts
- 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
Other
- Subjects who are reliant on partial or total parenteral nutrition
- 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)
- Pregnant women, women who are breast feeding, or women planning on becoming pregnant
- Unable to read English or provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Human Nutrition Research Unit Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.