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Completed

NCT Number: NCT05382897

Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-based fasting-mimicking diet

Other

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.

Primary outcomes

  1. 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]

Secondary outcomes

  1. 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

  2. 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

  3. Changes in clinical markers of disease

    Time frame: From baseline through 12 and 24 weeks

    Changes in serum C-reactive protein (CRP)

  4. Changes in clinical markers of disease

    Time frame: From baseline through 12 and 24 weeks

    Changes in fecal calprotectin

  5. 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)

  6. 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)

  7. 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)

  8. Changes in weight

    Time frame: From baseline through 12 and 24 weeks

    Changes in weight in kilograms

  9. 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

  10. 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

  11. 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)

  12. 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)

  13. Changes in gut microbiome

    Time frame: From baseline through 12 and 24 weeks

    Changes in gut microbiome as assessed by 16s rRNA analysis

  14. 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

  15. Changes in fecal bile acids

    Time frame: From baseline through 12 and 24 weeks

    Changes in fecal concentrations of primary and secondary bile acids

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • W. Garfield Weston Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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