Status:
COMPLETED
Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
W. Garfield Weston Foundation
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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 decrease...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05382897
Start Date
July 1 2022
End Date
February 2 2025
Last Update
September 11 2025
Active Locations (2)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2E1
2
University of Alberta Human Nutrition Research Unit
Edmonton, Alberta, Canada, T6G 2E1