Caloric-Sufficient Diet for Inflammatory Bowel Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta Human Nutrition Research Unit, Edmonton, Canada
Inflammatory Bowel Diseases+4 More
Plant-based fasting-mimicking diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Inflammatory Bowel Diseases
  • Ulcerative Colitis
  • Ileocolitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Inflammatory Bowel Diseases

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: From baseline through 12 and 24 weeks

Week 24
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Changes in Patient Health Questionnaire (PHQ-9)
Changes in blood cytokines
Changes in blood hormones
Changes in body mass index (BMI)
Changes in clinical markers of disease
Changes in fecal bile acids
Changes in fecal short chain fatty acids
Changes in gene expression in peripheral blood mononuclear cells
Changes in general anxiety
Changes in gut microbiome
Changes in levels of fatigue
Changes in partial Mayo Score in patients with ulcerative colitis
Changes in quality of Life
Changes in weight

Trial Safety

Safety Progress

1 of 3

Other trials for Inflammatory Bowel Diseases

Trial Design

2 Treatment Groups

Caloric-Sufficient Diet
1 of 2
Fasting-Mimicking Diet
1 of 2
Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Caloric-Sufficient Diet · No Placebo Group · Phase < 1

Caloric-Sufficient Diet
Other
Experimental Group · 1 Intervention: Plant-based fasting-mimicking diet · Intervention Types: Other
Fasting-Mimicking Diet
Other
Experimental Group · 1 Intervention: Plant-based fasting-mimicking diet · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline through 12 and 24 weeks
Closest Location: University of Alberta Human Nutrition Research Unit · Edmonton, Canada
Photo of Edmonton  1Photo of Edmonton  2Photo of Edmonton  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Inflammatory Bowel Diseases
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 65 years.
You have mild-moderate depression with PHQ-9 ≥5 and ≤ 19.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.