Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Launched by UNIVERSITY OF ALBERTA · May 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special diet, called a fasting-mimicking diet, on people with inflammatory bowel disease (IBD) who are also experiencing symptoms of depression. IBD includes conditions like Crohn's disease and ulcerative colitis, which cause inflammation in the intestines. The researchers want to see if this diet can help improve mood and mental health by looking at how it affects gut health, the immune system, and metabolic functions. Participants will follow the diet for five days at a time, with periods of regular eating in between, to see how their symptoms change.

To join this study, you need to be between 18 and 65 years old and have a diagnosis of mild to moderate IBD along with mild to moderate depression. However, there are certain health conditions that would exclude someone from participating, like having diabetes or a history of serious mental health issues. If you qualify and decide to participate, you will be monitored throughout the trial to assess how the diet impacts your mood and overall health. This study aims to find a safe and effective way to help improve mental well-being in people living with IBD.

Gender

ALL

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