Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

September 4, 2025 updated by: University of Alberta

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Patient Health Questionnaire (PHQ-9)
Time Frame: 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]
From baseline through 12 and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Time Frame: From baseline through 12 and 24 weeks
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
Time Frame: From baseline through 12 and 24 weeks
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
Time Frame: From baseline through 12 and 24 weeks
Changes in serum C-reactive protein (CRP)
From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Time Frame: From baseline through 12 and 24 weeks
Changes in fecal calprotectin
From baseline through 12 and 24 weeks
Changes in levels of fatigue
Time Frame: 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)
From baseline through 12 and 24 weeks
Changes in general anxiety
Time Frame: 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)
From baseline through 12 and 24 weeks
Changes in quality of Life
Time Frame: 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)
From baseline through 12 and 24 weeks
Changes in weight
Time Frame: From baseline through 12 and 24 weeks
Changes in weight in kilograms
From baseline through 12 and 24 weeks
Changes in body mass index (BMI)
Time Frame: From baseline through 12 and 24 weeks
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
Time Frame: From baseline through 12 and 24 weeks
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
Time Frame: 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)
From baseline through 12 and 24 weeks
Changes in blood hormones
Time Frame: From baseline through 12 and 24 weeks
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
From baseline through 12 and 24 weeks
Changes in gut microbiome
Time Frame: From baseline through 12 and 24 weeks
Changes in gut microbiome as assessed by 16s rRNA analysis
From baseline through 12 and 24 weeks
Changes in fecal short chain fatty acids
Time Frame: From baseline through 12 and 24 weeks
Changes in fecal concentrations of short chain fatty acids
From baseline through 12 and 24 weeks
Changes in fecal bile acids
Time Frame: From baseline through 12 and 24 weeks
Changes in fecal concentrations of primary and secondary bile acids
From baseline through 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
W. Garfield Weston Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Madsen, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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