Clinical trial NCT05382897: Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
Official title: Effects of a Fasting Mimicking Diet on Depressive Symptoms in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: depression
diet
microbiome
fasting
inflammatory bowel disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: W. Garfield Weston Foundation
First posted: 2022-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Changes in Patient Health Questionnaire (PHQ-9)
timeFrame: From baseline through 12 and 24 weeks
Secondary outcomes:
measure: Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in partial Mayo Score in patients with ulcerative colitis
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in clinical markers of disease
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in clinical markers of disease
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in levels of fatigue
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in general anxiety
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in quality of Life
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in weight
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in body mass index (BMI)
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in gene expression in peripheral blood mononuclear cells
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in blood cytokines
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in blood hormones
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in gut microbiome
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in fecal short chain fatty acids
timeFrame: From baseline through 12 and 24 weeks
measure: Changes in fecal bile acids
timeFrame: From baseline through 12 and 24 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Human Nutrition Research Unit
state: Alberta
Study officials:
affiliation: University of Alberta
name: Karen Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: