Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

NCT05382897 | Completed

• 1 other identifier: Pro00115405
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

depression; diet; microbiome; fasting; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease

  From baseline through 12 and 24 weeks

• Changes in partial Mayo Score in patients with ulcerative colitis

  From baseline through 12 and 24 weeks

• Changes in clinical markers of disease

  From baseline through 12 and 24 weeks

• Changes in clinical markers of disease

  From baseline through 12 and 24 weeks

• Changes in levels of fatigue

  From baseline through 12 and 24 weeks

Study Arms (2)

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.

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.

Other: Plant-based fasting-mimicking diet

Interventions

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.

Caloric-Sufficient Diet; Fasting-Mimicking Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• W. Garfield Weston Foundation: collaborator

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Location

University of Alberta Human Nutrition Research Unit

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Depression; Fasting

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavioral Symptoms; Behavior; Feeding Behavior

Study Officials

• Karen Madsen, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and lab personnel involved in assessment of outcomes will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: May 19, 2022
• Study Start: July 1, 2022
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)