Fasting-Mimicking Diet for Inflammatory Bowel Disease-Related Depression

Recruiting at 1 trial location

Overseen By Naomi Hotte, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Diabetes, Celiac, Psychotic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special diet that mimics fasting might benefit people with inflammatory bowel disease (IBD) who also experience depression. Participants will follow a plant-based fasting-mimicking diet, low in calories for five days each month, or another diet sufficient in calories, over three months. Researchers aim to determine if this dietary approach can improve gut health and reduce depression symptoms. This trial suits individuals with Crohn's disease or ulcerative colitis in mild or moderate stages, who also have mild to moderate depression. As an unphased trial, it offers a unique opportunity to explore innovative dietary approaches that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a fasting-mimicking diet might be safe for people with inflammatory bowel disease (IBD). In various studies, this diet has demonstrated potential in reducing gut inflammation and improving gut health. For instance, some research found that following a fasting-mimicking diet in cycles reduced inflammation and even helped repair gut tissue in mice with IBD.

Another study showed that this diet decreased intestinal inflammation and increased the number of intestinal stem cells, which are crucial for maintaining a healthy gut lining. These findings suggest that the diet is generally well-tolerated and may offer benefits without major side effects.

While these studies are promising, it is important to note that most findings come from animal research. Human studies are still needed to confirm these effects. However, current evidence suggests that a fasting-mimicking diet is generally safe for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the fasting-mimicking diet for inflammatory bowel disease-related depression because it offers a unique, dietary approach that could complement or even reduce reliance on traditional medication. Unlike standard treatments that typically involve medications like antidepressants or anti-inflammatory drugs, this diet mimics fasting, potentially reducing inflammation and improving mood through natural, plant-based means. Additionally, the diet is only followed for five days each month, providing a manageable and less intrusive lifestyle change for participants. This novel approach taps into the body's natural processes, which might lead to fewer side effects and a holistic improvement in well-being.

What evidence suggests that this trial's treatments could be effective for IBD-related depression?

Research has shown that a diet similar to fasting can affect gut health, potentially reducing depression in people with inflammatory bowel disease (IBD). In this trial, participants will join one of two treatment arms. One group will follow a plant-based fasting-mimicking diet, while the other will adhere to a plant-based caloric-sufficient diet. Studies have found that a fasting-mimicking diet can alter the gut microbiome, the group of bacteria living in the intestines, to improve gut health and lower inflammation. This is significant because inflammation and gut bacteria are linked to both IBD and depression. Early findings suggest that a fasting-like diet might enhance mental health by fostering a healthier gut environment. Although more research is needed, the initial results are promising for those with depression related to IBD. ^{1 6 7 8 9}

Who Is on the Research Team?

Karen Madsen, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Plant-based fasting-mimicking diet

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.

How Is the Trial Designed?

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+

W. Garfield Weston Foundation

Collaborator

Trials

3

Recruited

190+

Published Research Related to This Trial

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 (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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05382897

Fasting-mimicking Diet in Treatment of Depressive Symptoms in ... 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), From ...

2. withpower.com withpower.com/trial/early-phase-1-depression-5-2022-6838c

Fasting-Mimicking Diet for Inflammatory Bowel Disease ... 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6528490/

Fasting-Mimicking Diet Modulates Microbiota and Promotes ... Fasting-mimicking diet modulates microbiota and promotes intestinal regeneration to reduce inflammatory bowel disease pathology.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05382897/fasting-mimicking-diet-in-treatment-of-depressive-symptoms-in-ibd

Fasting-mimicking Diet in Treatment of Depressive ... 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 ...

5. studies.bethecure.ca studies.bethecure.ca/find/26c39bac0cbf6c24f742c7cbad4708f8fe860252-effects-of-a-fasting-mimicking-diet-on-depressi

Fasting-mimicking Diet in Treatment of Depressive Symptoms ... 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.

6. gero.usc.edu gero.usc.edu/2019/03/05/fasting-mimicking-diet-holds-promise-for-treating-people-with-inflammatory-bowel-disease-usc-study-finds/

Fasting-mimicking diet holds promise for treating people ... Results showed that fasting-mimicking diet caused a reduction in intestinal inflammation and an increase in intestinal stem cells in part by ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03615690

The Influence of a Fasting Mimicking Diet on Ulcerative ... The purpose of this study is to see how a diet that mimics fasting effects inflammation in patients with mild to moderate Ulcerative Colitis (UC).

8. nih.gov nih.gov/news-events/nih-research-matters/reduced-calorie-diet-lowers-signs-inflammatory-bowel-disease

Reduced-calorie diet lowers signs of inflammatory bowel ... In the mice given cycles of the fasting-mimicking diet, gut inflammation and other signs of IBD improved. The researchers also observed that the ...

9. medicalnewstoday.com medicalnewstoday.com/articles/324634

IBD: A low-calorie plant diet relieves inflammation, repairs gut Cycles of a low-calorie, plant-based diet reduced inflammation, prompted tissue repair, and promoted good bacteria in intestines of mice ...