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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

Must not have

Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy

Subjects who are reliant on partial or total parenteral nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through 12 and 24 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart, lung diseases, or active cancer.

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I rely on nutrition given through my veins.

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I have had surgery on my digestive system that affects how it works.

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I have a history of severe mental health issues like psychosis or bipolar disorder.

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I have an immune-compromised condition, but it's not inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through 12 and 24 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Patient Health Questionnaire (PHQ-9)

Secondary study objectives

Changes in Harvey-Bradshaw Index (HBI) in patients with Crohn's disease

Changes in blood cytokines

Changes in blood hormones

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met