Inflammatory Bowel DiseasesNCT05382897
Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
A study testing Plant-based fasting-mimicking diet in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Plant-based fasting-mimicking diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2022to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2E1
University of Alberta Human Nutrition Research Unit
Edmonton, Alberta, T6G 2E1
About this study
Official title: 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.
Read the 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:
- Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis
- Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting
- Examine effects of the intervention on the gut microbiome and metabolome
- Being tested
- Plant-based fasting-mimicking diet
- Keywords
- depression, diet, microbiome, fasting, inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Depression, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based fasting-mimicking dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting-Mimicking Diet | Experimental | 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. Receives: Other: Plant-based fasting-mimicking diet |
| Caloric-Sufficient Diet | Experimental | 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. Receives: Other: Plant-based fasting-mimicking diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: From baseline through 12 and 24 weeks
Secondary outcomes (15)
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
Measured: 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
Measured: From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Changes in serum C-reactive protein (CRP)
Measured: From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Changes in fecal calprotectin
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline through 12 and 24 weeks
Changes in weight
Changes in weight in kilograms
Measured: 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
Measured: 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
Measured: 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)
Measured: From baseline through 12 and 24 weeks
Changes in blood hormones
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
Measured: From baseline through 12 and 24 weeks
Changes in gut microbiome
Changes in gut microbiome as assessed by 16s rRNA analysis
Measured: From baseline through 12 and 24 weeks
Changes in fecal short chain fatty acids
Changes in fecal concentrations of short chain fatty acids
Measured: From baseline through 12 and 24 weeks
Changes in fecal bile acids
Changes in fecal concentrations of primary and secondary bile acids
Measured: From baseline through 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jul 2022
- Primary completion2 Feb 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an exploratory randomized double-blind parallel trial using a fasting-mimicking diet (FMD) in patients with inflammatory bowel disease (IBD) who are in clinical remission but experiencing depression
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- W. Garfield Weston Foundation
- Responsible party
- Sponsor
- Investigators
- Karen Madsen, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382897
- Sponsor's protocol ID
- Pro00115405
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05382897
- Acronym / sponsor ID
- Pro00115405
- Keywords
- depression, diet, microbiome, fasting, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- W. Garfield Weston Foundation
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 2 Feb 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis
- Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting
- Examine effects of the intervention on the gut microbiome and metabolome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an exploratory randomized double-blind parallel trial using a fasting-mimicking diet (FMD) in patients with inflammatory bowel disease (IBD) who are in clinical remission but experiencing depression
| Arm | Type | Receives |
|---|---|---|
| Fasting-Mimicking Diet | Experimental | Other: Plant-based fasting-mimicking dietParticipants 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 | Experimental | Other: Plant-based fasting-mimicking dietParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based fasting-mimicking dietParticipants 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. | Other | Caloric-Sufficient Diet, Fasting-Mimicking Diet |
Primary outcome
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]
15 secondary outcomes
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Time frame: 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 clinical markers of disease
Time frame: From baseline through 12 and 24 weeks
Changes in clinical markers of disease
Time frame: From baseline through 12 and 24 weeks
Changes in levels of fatigue
Time frame: From baseline through 12 and 24 weeks
Changes in general anxiety
Time frame: From baseline through 12 and 24 weeks
Changes in quality of Life
Time frame: From baseline through 12 and 24 weeks
Changes in weight
Time frame: From baseline through 12 and 24 weeks
Changes in body mass index (BMI)
Time frame: 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 blood cytokines
Time frame: From baseline through 12 and 24 weeks
Changes in blood hormones
Time frame: From baseline through 12 and 24 weeks
Changes in gut microbiome
Time frame: 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 bile acids
Time frame: From baseline through 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Madsen, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based fasting-mimicking diet in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Patient Health Questionnaire (PHQ-9) (time frame: From baseline through 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.