Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

NCT ID: NCT05382897

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-02-02

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.

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

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Plant-based fasting-mimicking diet

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Plant-based fasting-mimicking diet

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W. Garfield Weston Foundation

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Madsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

University of Alberta Human Nutrition Research Unit

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00115405

Identifier Type: -

Identifier Source: org_study_id