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Fasting-Mimicking Diet for Inflammatory Bowel Disease-Related Depression

Phase < 1
Recruiting
Led By Karen Madsen, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19
Age ≥ 18 and ≤ 65 years at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through 12 and 24 weeks
Awards & highlights

Study Summary

This trial is investigating the effects of a fasting mimicking diet on IBD patients who are suffering from symptoms of depression. The 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.

Who is the study for?
This trial is for adults aged 18-65 with Crohn's disease or ulcerative colitis in remission, who are experiencing mild to moderate depression. They must not be underweight, malnourished, have a severe illness like AIDS or cancer, be pregnant or breastfeeding, have had certain gastrointestinal surgeries, suffer from diabetes or celiac disease, nor have a history of psychotic disorders.Check my eligibility
What is being tested?
The study tests the effects of a fasting-mimicking diet on depressive symptoms in IBD patients. Participants will alternate between a low-calorie plant-based diet for 5 days and their normal diet for 3 weeks over several cycles. The focus is on how this diet affects gut microbes and mental health.See study design
What are the potential side effects?
Potential side effects may include fatigue due to calorie restriction, digestive discomfort as the body adjusts to the plant-based regimen, and possible nutrient deficiencies if not properly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild to moderate depression.
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I am between 18 and 65 years old.
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My Crohn's disease or ulcerative colitis is currently in remission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through 12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Patient Health Questionnaire (PHQ-9)
Secondary outcome measures
Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease
Changes in blood cytokines
Changes in blood hormones
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Fasting-Mimicking DietExperimental Treatment1 Intervention
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.
Group II: Caloric-Sufficient DietExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,014 Total Patients Enrolled
W. Garfield Weston FoundationUNKNOWN
2 Previous Clinical Trials
72 Total Patients Enrolled
Karen Madsen, PhDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
136 Total Patients Enrolled

Media Library

Plant-based fasting-mimicking diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05382897 — Phase < 1
Inflammatory Bowel Disease Research Study Groups: Fasting-Mimicking Diet, Caloric-Sufficient Diet
Inflammatory Bowel Disease Clinical Trial 2023: Plant-based fasting-mimicking diet Highlights & Side Effects. Trial Name: NCT05382897 — Phase < 1
Plant-based fasting-mimicking diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382897 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to sign up for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting patients; it was originally published on July 1st 2022 and has been recently revised. This trial seeks 120 individuals from two different investigation centres."

Answered by AI

Is it possible to join this experiment?

"This clinical trial is searching for 120 individuals aged 18-65 with inflammatory bowel diseases. Qualified applicants must be experiencing mild-moderate depression (PHQ-9 5 to 19), have Crohn's disease in remission (Harvey Bradshaw Index below 5) or ulcerative colitis in remission (partial Mayo score lower than 2)."

Answered by AI

How many individuals have been recruited for this clinical trial thus far?

"Affirmative. Clinicaltrials.gov records indicate that this medical experiment, first publicized on July 1st 2022 is still recruiting participants. Approximately 120 individuals are needed from two distinct locations."

Answered by AI

Is the target demographic of this experiment exclusively adults aged 18 and older?

"Adhering to the eligibility restrictions of this medical trial, participants must be 18 years old at a minimum and 65 or younger."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD
2022. "Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05382897.
All > Inflammatory Bowel Disease > Microbiome
~10 spots leftby Jul 2024
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