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Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Plant-based fasting-mimicking diet
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring depression, diet, microbiome, fasting, inflammatory bowel disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta HospitalRecruiting
  • University of Alberta Human Nutrition Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fasting-Mimicking Diet

Caloric-Sufficient Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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
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
Changes in clinical markers of disease
Changes in serum C-reactive protein (CRP)
Changes in clinical markers of disease
Changes in fecal calprotectin
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)
Changes in general anxiety
Changes in general anxiety as assessed by the Hospital Anxiety and Depression scale (HADS) (0-21; low to high)
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)
Changes in weight
Changes in weight in kilograms
Changes in body mass index (BMI)
Changes in BMI as assessed by weight in kilograms divided by the square of height in meters
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
Changes in blood cytokines
Changes in plasma concentrations of cytokines (TNF, IL-6, IL-8, IFNγ, IL-1β, IL-9, IL-10, IL-12, IL-17, TGFβ)
Changes in blood hormones
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
Changes in gut microbiome
Changes in gut microbiome as assessed by 16s rRNA analysis
Changes in fecal short chain fatty acids
Changes in fecal concentrations of short chain fatty acids
Changes in fecal bile acids
Changes in fecal concentrations of primary and secondary bile acids

Full Information

First Posted
January 31, 2022
Last Updated
July 12, 2023
Sponsor
University of Alberta
Collaborators
W. Garfield Weston Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05382897
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
W. Garfield Weston Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting Examine effects of the intervention on the gut microbiome and metabolome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Keywords
depression, diet, microbiome, fasting, inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigator and lab personnel involved in assessment of outcomes will be blinded to the group allocation.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting-Mimicking Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Caloric-Sufficient Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Plant-based fasting-mimicking diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Patient Health Questionnaire (PHQ-9)
Description
A change in depressive symptoms as assessed through the Patient Health Questionnaire (PHQ)-9. [Min:0; Max 27; good to poor]
Time Frame
From baseline through 12 and 24 weeks
Secondary Outcome Measure Information:
Title
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Description
Changes in disease status as assessed by HBI in Crohn's disease patients
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in partial Mayo Score in patients with ulcerative colitis
Description
Changes in disease status as assessed by partial Mayo Score in patients with ulcerative colitis
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in clinical markers of disease
Description
Changes in serum C-reactive protein (CRP)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in clinical markers of disease
Description
Changes in fecal calprotectin
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in levels of fatigue
Description
Changes in level of fatigue as assessed by the inflammatory bowel disease-fatigue (IBD-F) self-assessment scale (0-20; low to high)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in general anxiety
Description
Changes in general anxiety as assessed by the Hospital Anxiety and Depression scale (HADS) (0-21; low to high)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in quality of Life
Description
Changes in quality of life as assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (score 10-70, poor to good)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in weight
Description
Changes in weight in kilograms
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in body mass index (BMI)
Description
Changes in BMI as assessed by weight in kilograms divided by the square of height in meters
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in gene expression in peripheral blood mononuclear cells
Description
Changes in immune function as assessed by changes in gene expression of peripheral blood mononuclear cells
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in blood cytokines
Description
Changes in plasma concentrations of cytokines (TNF, IL-6, IL-8, IFNγ, IL-1β, IL-9, IL-10, IL-12, IL-17, TGFβ)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in blood hormones
Description
Changes in plasma concentrations of hormones (ghrelin, leptin, BDNF, GLP-1, glucagon, insulin)
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in gut microbiome
Description
Changes in gut microbiome as assessed by 16s rRNA analysis
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in fecal short chain fatty acids
Description
Changes in fecal concentrations of short chain fatty acids
Time Frame
From baseline through 12 and 24 weeks
Title
Changes in fecal bile acids
Description
Changes in fecal concentrations of primary and secondary bile acids
Time Frame
From baseline through 12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Madsen, PhD
Phone
78045925257
Email
karen.madsen@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Hotte, MSc
Phone
7804927077
Email
nhotte@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Madsen, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Madsen, PhD
Facility Name
University of Alberta Human Nutrition Research Unit
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Madsen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cegiir.med.ualberta.ca/
Description
The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research

Learn more about this trial

Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

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