Fasting-Mimicking Diet for Inflammatory Bowel Disease-Related Depression

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Karen Madsen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Alberta

Disqualifiers: Diabetes, Celiac, Psychotic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the fasting-mimicking diet treatment for inflammatory bowel disease-related depression?

Research suggests that a plant-based diet may help reduce inflammation in inflammatory bowel disease (IBD) patients, which could potentially improve symptoms. Additionally, a plant-based diet has been shown to induce remission in some cases of mild ulcerative colitis, a type of IBD. ^{1 2 3 4 5}

How is the fasting-mimicking diet treatment different from other treatments for inflammatory bowel disease-related depression?

The fasting-mimicking diet is unique because it involves a plant-based, low-calorie approach that mimics the effects of fasting, potentially offering benefits for inflammatory bowel disease-related depression by altering gut microbiota and reducing inflammation, unlike traditional diets that may not have these specific effects. ^{1 6 7 8 9}

Research Team

Karen Madsen, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

Inclusion Criteria

I have mild to moderate depression.

I am between 18 and 65 years old.

My Crohn's disease or ulcerative colitis is currently in remission.

Exclusion Criteria

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

Subjects with a body mass index (BMI) lower than 18

Subjects currently on a fasting/intermittent type caloric restricted diet

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Baseline Assessment

Participants are followed for baseline assessment before starting the diet intervention

3 weeks

1 visit (in-person)

Treatment

Participants consume a plant-based fasting-mimicking diet or a caloric-sufficient diet for 5 days once a month for 3 months

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms, gut microbiome, and other health markers

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Plant-based fasting-mimicking diet (Other)

Trial Overview 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.

Participant Groups

Group I: Fasting-Mimicking Diet Experimental Treatment 1 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 Diet Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

W. Garfield Weston Foundation

Collaborator

Trials

3

Recruited

190+

Findings from Research

In a study of 434 patients with inflammatory bowel disease (IBD), about 36.6% totally excluded at least one food category, and 62.4% partially excluded foods, indicating a significant prevalence of exclusion diets among these patients.

Approximately 30.8% of patients reported some form of fasting, with disease activity and specific treatments being linked to both exclusion diets and fasting behaviors, suggesting that dietary management could play a crucial role in their clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food avoidance and fasting in patients with inflammatory bowel disease: Experience from the Nancy IBD nutrition clinic. Bonsack, O., Caron, B., Baumann, C., et al.[2023]

A plant-based diet may help reduce inflammation and improve the gut microbiome in patients with Inflammatory Bowel Disease (IBD), potentially enhancing their quality of life.

Current evidence suggests that a Westernized diet is linked to increased risk and relapse of IBD, highlighting the need for more rigorous studies to confirm the benefits of dietary modifications in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of a plant-based diet in the pathogenesis, etiology and management of the inflammatory bowel diseases. Grosse, CSJ., Christophersen, CT., Devine, A., et al.[2021]

A plant-based diet (PBD) was effective in inducing remission in a 34-year-old woman with mild ulcerative colitis, as her stool normalized and inflammatory markers improved during a 19-day educational hospitalization.

When the PBD alone was insufficient for sustained remission, medication (sulfasalazine) was introduced, leading to normal stool formation and confirmed endoscopic remission, highlighting a personalized approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepwise Treatment With Plant-Based Diet and Medication for Patient With Mild Ulcerative Colitis. Chiba, M., Tsuji, T., Ohno, H., et al.[2022]

In a study of 71 patients with inflammatory bowel disease (IBD), those with active disease reported significantly poorer sleep quality, higher levels of depression and anxiety, and lower quality of life compared to those in remission.

Dietary factors did not correlate with disease activity, but the study identified that not being breastfed and consuming spicy foods could increase the risk of developing IBD, while having no siblings might offer some protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation Between Sleep, Life, Mood, and Diet and Severity of Inflammatory Bowel Disease in China: A Retrospective Study. Xu, J., Chen, X., Ma, K., et al.[2022]

Patients with inflammatory bowel disease (IBD) in clinical remission consume more calories and fats but less fiber compared to healthy individuals, indicating a distinct dietary pattern even without symptoms.

The study involved 150 IBD patients (84 with Crohn's disease and 66 with ulcerative colitis) and 100 healthy controls, suggesting that psychological factors may influence dietary choices in IBD patients despite no required dietary restrictions during remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in dietary habits between patients with inflammatory bowel disease in clinical remission and a healthy population. Principi, M., Losurdo, G., Iannone, A., et al.[2022]

In a study of 1254 IBD patients, only a small percentage (4.1% for vegetarian diets and 4.7% for gluten-free diets) reported following restrictive diets, and these diets did not significantly affect disease activity or hospitalization rates.

However, patients on vegetarian or gluten-free diets experienced higher levels of anxiety, depression, and post-traumatic stress symptoms, indicating a potential negative impact on psychological well-being despite no direct effect on their IBD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vegetarian or gluten-free diets in patients with inflammatory bowel disease are associated with lower psychological well-being and a different gut microbiota, but no beneficial effects on the course of the disease. Schreiner, P., Yilmaz, B., Rossel, JB., et al.[2020]

Three patients with inflammatory bowel disease also had eating disorders, highlighting a potential link between these conditions.

Two patients used milk ingestion as a purgative method, which is particularly concerning given their lactose intolerance, suggesting a dangerous coping mechanism related to their eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating disorders in inflammatory bowel disease. Gryboski, JD.[2015]

A survey of 244 inflammatory bowel disease (IBD) patients revealed that 56% believe food can trigger disease relapses, highlighting a common concern among patients regarding dietary management.

Many patients (67%) actively avoid certain foods they enjoy to prevent relapses, indicating that IBD significantly affects their eating habits and social interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What physicians don't know about patient dietary beliefs and behavior can make a difference. Kane, S.[2012]

The review highlights various dietary approaches, including exclusive enteral nutrition (EEN), the Specific Carbohydrate Diet (SCD), and the low FODMAP diet, which may influence inflammation in inflammatory bowel disease (IBD).

While no specific macronutrient has been consistently linked to the development of IBD, exclusion diets show promise in managing symptoms, though the existing data has both strengths and limitations that need to be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet as a Therapeutic Option for Adult Inflammatory Bowel Disease. Kakodkar, S., Mutlu, EA.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Food avoidance and fasting in patients with inflammatory bowel disease: Experience from the Nancy IBD nutrition clinic. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The role of a plant-based diet in the pathogenesis, etiology and management of the inflammatory bowel diseases. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Stepwise Treatment With Plant-Based Diet and Medication for Patient With Mild Ulcerative Colitis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Correlation Between Sleep, Life, Mood, and Diet and Severity of Inflammatory Bowel Disease in China: A Retrospective Study. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Differences in dietary habits between patients with inflammatory bowel disease in clinical remission and a healthy population. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Vegetarian or gluten-free diets in patients with inflammatory bowel disease are associated with lower psychological well-being and a different gut microbiota, but no beneficial effects on the course of the disease. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Eating disorders in inflammatory bowel disease. [2015]

8. England pubmed.ncbi.nlm.nih.gov

What physicians don't know about patient dietary beliefs and behavior can make a difference. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Diet as a Therapeutic Option for Adult Inflammatory Bowel Disease. [2018]