Dietary Interventions for Inflammatory Bowel Disease

(AID-IBD Trial)

Recruiting at 1 trial location

Overseen By Vanina Noejovich, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Pregnancy, Eating disorders, Schizophrenia, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets can help individuals with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease. It examines adherence to eating plans like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet, and their effects on IBD symptoms. The goal is to identify diets that improve daily life for those with IBD. Individuals diagnosed with ulcerative colitis or Crohn's disease who are open to trying a new diet might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore dietary changes that could enhance quality of life for those with IBD.

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 focuses on dietary changes for people with inflammatory bowel disease.

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

Research has shown that the diets tested for inflammatory bowel disease (IBD) are generally safe.

For the intermittent fasting method, studies suggest it can reduce gut inflammation and improve immune function. Although fasting might not change some inflammation markers, it has been linked to improvements in colitis, which is inflammation of the colon's inner lining, in certain cases.

The low FODMAP diet limits certain hard-to-digest carbohydrates and is considered safe for people with IBD. Research indicates it can ease gut symptoms without affecting the disease's inflammation levels.

The Mediterranean diet, rich in fruits, vegetables, and healthy fats, is linked to reduced gut inflammation and improved quality of life. Studies suggest it may help manage IBD with few side effects.

Overall, these diets are well-tolerated and may help manage IBD symptoms with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions for inflammatory bowel disease (IBD) because they offer a fresh approach compared to the standard treatments, which often rely on medications like anti-inflammatory drugs, immune system suppressors, and biologics. Unlike these traditional options, the intermittent fasting protocol may help reduce inflammation by giving the digestive system a break, potentially resetting immune responses naturally. The Low FODMAP Diet aims to alleviate symptoms by reducing certain carbohydrates that are hard to digest, which can decrease gut irritation. Meanwhile, the Mediterranean Diet is rich in anti-inflammatory foods like fruits, vegetables, and healthy fats, which might improve gut health and reduce flare-ups. These dietary approaches are non-pharmacological, focusing on the root causes of inflammation and digestion issues in a way that many current medical treatments do not.

What evidence suggests that this trial's dietary interventions could be effective for IBD?

This trial will compare the effects of different dietary interventions on inflammatory bowel disease (IBD). Participants will be assigned to one of the following treatment arms: Intermittent Fasting, Low FODMAP Diet, or Mediterranean Diet.

Research shows that intermittent fasting can reduce intestinal inflammation, which may benefit people with IBD. Studies have found that this eating pattern can make the intestines less "leaky" and lower overall inflammation. Evidence suggests that while the Low FODMAP diet does not alter the disease itself, it helps alleviate gut symptoms like bloating and stomach pain for many individuals. Lastly, the Mediterranean diet has been found to improve quality of life and reduce inflammation in IBD patients. It positively affects gut health and is linked to better disease management and symptom relief. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with IBD, including Ulcerative Colitis and Crohn's Disease. Participants should be interested in testing how different diets may impact their condition.

Inclusion Criteria

I am willing to use my smartphone for the trial app.

Able to understand the indication by the registered dietitian

Able to provide informed consent

Exclusion Criteria

I have diabetes.

I have advanced chronic kidney disease.

I have short bowel syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow assigned dietary interventions: intermittent fasting, Mediterranean diet, or Low FODMAP diet

8-12 weeks

Follow-up

Participants are monitored for adherence and perceived benefits of dietary interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting Intervention
• Low FODMAP Diet Intervention
• Mediterranean Diet Intervention

Trial Overview The study examines the effects of three diet interventions on IBD symptoms: intermittent fasting, Mediterranean diet, and Low FODMAP diet. It also assesses participants' adherence to these eating plans.

How Is the Trial Designed?

Group I: Mediterranean Diet Experimental Treatment 1 Intervention

Participants will be assigned to follow a Mediterranean diet.

Group II: Low FODMAP Diet Experimental Treatment 1 Intervention

Participants will be assigned to follow a Low FODMAP Diet.

Group III: Intermittent Fasting Experimental Treatment 1 Intervention

Participants will be assigned to follow an intermittent fasting protocol.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

In a study of 100 children and adolescents with mild to moderate inflammatory bowel disease (IBD), those who adhered to the Mediterranean diet (MD) for 12 weeks showed significant improvements in disease activity and inflammatory markers compared to those on their usual diet.

Patients following the MD experienced earlier and greater reductions in clinical scores and inflammatory markers, indicating that the MD may be a beneficial dietary intervention for managing IBD in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean Diet Improved Clinical Scores and Inflammatory Markers in Children with Active Inflammatory Bowel Disease: A Randomized Trial. El Amrousy, D., Elashry, H., Salamah, A., et al.[2022]

A low FODMAP diet significantly improves gastrointestinal symptoms in patients with inflammatory bowel disease (IBD), including reductions in diarrhea, abdominal pain, bloating, fatigue, and nausea, based on a meta-analysis of 319 patients.

The analysis indicates that while the diet is effective for most symptoms, it did not show a significant impact on constipation, highlighting the need for further research to confirm these findings and explore long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is a low FODMAP diet beneficial for patients with inflammatory bowel disease? A meta-analysis and systematic review. Zhan, YL., Zhan, YA., Dai, SX.[2019]

In a study of 205 IBS patients followed for an average of 44 months, 60% reported adequate symptom relief while adhering to a personalized low FODMAP diet (pLFD).

Most participants (80%) continued to consume 'free-from' products, particularly gluten or wheat-free items, indicating a long-term commitment to dietary changes for managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low FODMAP diet for IBS; A multicentre UK study assessing long term follow up. Rej, A., Shaw, CC., Buckle, RL., et al.[2022]

Diet plays a significant role in the onset and severity of inflammatory bowel diseases (IBDs), as it can influence immune system regulation and intestinal health.

While enteral nutrition is effective for treating pediatric Crohn's disease, there is a lack of research on the impact of whole food dietary interventions, highlighting the need for further studies to explore dietary patterns and their potential in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet in Treatment of Inflammatory Bowel Diseases. Sasson, AN., Ananthakrishnan, AN., Raman, M.[2022]

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 systematic review of clinical trials found that dietary interventions, particularly exclusion diets and low FODMAP diets, may significantly improve symptoms in patients with inflammatory bowel disease (IBD).

Higher quality studies indicated that these specific dietary approaches were more effective than control diets, suggesting that diet can be an important part of the treatment plan for IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. Charlebois, A., Rosenfeld, G., Bressler, B.[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]

Current evidence on the impact of diet on adult inflammatory bowel disease (IBD) is limited, with many studies being small and not well-controlled, highlighting the need for larger, more rigorous clinical trials.

Diets such as Mediterranean, vegetarian/vegan, and reduced-calorie/fasting have shown promise in related immune-mediated inflammatory diseases and may be beneficial for IBD, while gluten-free and low FODMAP diets do not significantly affect IBD activity but may help with related gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. Jiang, Y., Jarr, K., Layton, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597193/

Effect of Intermittent Fasting on Immune Parameters and ... Long-term fasting decreased intestinal permeability [9] and the concentration of pro-inflammatory cytokines such as the tumor necrosis factor ( ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724015572

Exclusion diet and fasting practices in patients with ... A total of 434 patients with IBD were included. Undernutrition was observed in 25.8 % of the whole population at inclusion (15 % with moderate undernutrition ...

4. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1909/7971835

P1035 The Effects of an Intermittent Reduced Calorie Diet on ... Cycles of a short intermittent calorie restricted diet (IRCD) have been shown to improve inflammatory and metabolic outcomes in healthy subjects ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10240551/

A review of the role of intermittent fasting ... The results from animal studies suggest either moderate or no changes in weight but improvements in colitis with IF. These improvements may be ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1568163725001436

Long-term fasting and its influence on inflammatory ... Contrary to popular belief, the majority of studies reported either no change or an increase in inflammatory biomarkers during prolonged fasting. CRP levels ...