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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Other: Plant-based fasting-mimicking diet

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T6G 2E1
      • University of Alberta Human Nutrition Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Patient Health Questionnaire (PHQ-9)	A change in depressive symptoms as assessed through the Patient Health Questionnaire (PHQ)-9. [Min:0; Max 27; good to poor]	From baseline through 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease	Changes in disease status as assessed by HBI in Crohn's disease patients	From baseline through 12 and 24 weeks
Changes in partial Mayo Score in patients with ulcerative colitis	Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis	From baseline through 12 and 24 weeks
Changes in clinical markers of disease	Changes in serum C-reactive protein (CRP)	From baseline through 12 and 24 weeks
Changes in clinical markers of disease	Changes in fecal calprotectin	From baseline through 12 and 24 weeks
Changes in levels of fatigue	Changes in level of fatigue as assessed by the inflammatory bowel disease-fatigue (IBD-F) self-assessment scale (0-20; low to high)	From baseline through 12 and 24 weeks
Changes in general anxiety	Changes in general anxiety as assessed by the Hospital Anxiety and Depression scale (HADS) (0-21; low to high)	From baseline through 12 and 24 weeks
Changes in quality of Life	Changes in quality of life as assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (score 10-70, poor to good)	From baseline through 12 and 24 weeks
Changes in weight	Changes in weight in kilograms	From baseline through 12 and 24 weeks
Changes in body mass index (BMI)	Changes in BMI as assessed by weight in kilograms divided by the square of height in meters	From baseline through 12 and 24 weeks
Changes in gene expression in peripheral blood mononuclear cells	Changes in immune function as assessed by changes in gene expression of peripheral blood mononuclear cells	From baseline through 12 and 24 weeks
Changes in blood cytokines	Changes in plasma concentrations of cytokines (TNF, IL-6, IL-8, IFNγ, IL-1β, IL-9, IL-10, IL-12, IL-17, TGFβ)	From baseline through 12 and 24 weeks
Changes in blood hormones	Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)	From baseline through 12 and 24 weeks
Changes in gut microbiome	Changes in gut microbiome as assessed by 16s rRNA analysis	From baseline through 12 and 24 weeks
Changes in fecal short chain fatty acids	Changes in fecal concentrations of short chain fatty acids	From baseline through 12 and 24 weeks
Changes in fecal bile acids	Changes in fecal concentrations of primary and secondary bile acids	From baseline through 12 and 24 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: W. Garfield Weston Foundation
• Investigators: Principal Investigator: Karen Madsen, PhD, University of Alberta

Publications and helpful links

Helpful Links

• The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): February 2, 2025
• Study Completion (Actual): February 2, 2025

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: depression; diet; microbiome; inflammatory bowel disease; fasting
• Additional Relevant MeSH Terms: Intestinal Diseases; Behavioral Symptoms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Behavior; Feeding Behavior; Depression; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Fasting
• Other Study ID Numbers: Pro00115405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No