Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382897
• Other study ID #: Pro00115405
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: Karen Madsen, PhD
• Phone: 78045925257
• Email: karen.madsen[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age = 18 and = 65 years at the time of screening

• Diagnosis of Crohn's disease in clinical remission with Harvey Bradshaw Index (HBI<5) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo<2)

• 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

Related Conditions & MeSH terms

• Crohn Disease
• Depression
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	University of Alberta Human Nutrition Research Unit	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	W. Garfield Weston Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease	Changes in disease status as assessed by HBI in Crohn's disease patients	From baseline through 12 and 24 weeks
Secondary	Changes in partial Mayo Score in patients with ulcerative colitis	Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis	From baseline through 12 and 24 weeks
Secondary	Changes in clinical markers of disease	Changes in serum C-reactive protein (CRP)	From baseline through 12 and 24 weeks
Secondary	Changes in clinical markers of disease	Changes in fecal calprotectin	From baseline through 12 and 24 weeks
Secondary	Changes in levels of fatigue	Changes in level of fatigue as assessed by the inflammatory bowel disease-fatigue (IBD-F) self-assessment scale (0-20; low to high)	From baseline through 12 and 24 weeks
Secondary	Changes in general anxiety	Changes in general anxiety as assessed by the Hospital Anxiety and Depression scale (HADS) (0-21; low to high)	From baseline through 12 and 24 weeks
Secondary	Changes in quality of Life	Changes in quality of life as assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (score 10-70, poor to good)	From baseline through 12 and 24 weeks
Secondary	Changes in weight	Changes in weight in kilograms	From baseline through 12 and 24 weeks
Secondary	Changes in body mass index (BMI)	Changes in BMI as assessed by weight in kilograms divided by the square of height in meters	From baseline through 12 and 24 weeks
Secondary	Changes in gene expression in peripheral blood mononuclear cells	Changes in immune function as assessed by changes in gene expression of peripheral blood mononuclear cells	From baseline through 12 and 24 weeks
Secondary	Changes in blood cytokines	Changes in plasma concentrations of cytokines (TNF, IL-6, IL-8, IFN?, IL-1ß, IL-9, IL-10, IL-12, IL-17, TGFß)	From baseline through 12 and 24 weeks
Secondary	Changes in blood hormones	Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)	From baseline through 12 and 24 weeks
Secondary	Changes in gut microbiome	Changes in gut microbiome as assessed by 16s rRNA analysis	From baseline through 12 and 24 weeks
Secondary	Changes in fecal short chain fatty acids	Changes in fecal concentrations of short chain fatty acids	From baseline through 12 and 24 weeks
Secondary	Changes in fecal bile acids	Changes in fecal concentrations of primary and secondary bile acids	From baseline through 12 and 24 weeks

External Links

•   The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research