Mediterranean Diet for Inflammation Post-Colonoscopy

Overseen By Jack A Gilbert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Antibiotics, Insulin, Sulfonylureas, Glinides

Disqualifiers: Pregnant, Diabetes, Hypertension, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 7

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on medications that require dietary restrictions or are for chronic diseases, you may not be eligible to participate.

What data supports the effectiveness of the Modified Plant-Based Mediterranean Diet treatment for reducing inflammation after a colonoscopy?

Research shows that following a Mediterranean diet, which is rich in antioxidants and has anti-inflammatory effects, can improve inflammatory markers in people with inflammatory bowel diseases. This suggests it might help reduce inflammation after a colonoscopy as well. ^{1 2 3 4 5}

Is the Mediterranean Diet safe for humans?

The Mediterranean Diet has been studied in various conditions and is generally considered safe for humans. Studies have shown it can improve health markers and reduce inflammation without significant safety concerns. ^{1 4 5 6 7}

How does the Mediterranean Diet treatment differ from other treatments for inflammation after a colonoscopy?

The Mediterranean Diet treatment is unique because it focuses on a plant-based diet rich in antioxidants and anti-inflammatory foods, which can help reduce inflammation by promoting beneficial gut bacteria. Unlike other treatments that might involve medication, this approach uses dietary changes to manage inflammation. ^{1 4 5 8 9}

What is the purpose of this trial?

This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.

Eligibility Criteria

This trial is for individuals scheduled for their 2nd or 3rd colonoscopy who previously had certain types of polyps but currently do not have colorectal cancer. It's designed to see if a modified plant-based Mediterranean diet can improve gut health and reduce inflammation after the procedure.

Inclusion Criteria

I am due for my 2nd or 3rd colonoscopy and have had certain types of polyps but no current colon cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a modified plant-based Mediterranean diet post-colonoscopy to reduce inflammation and improve gut microbiome composition.

4 weeks

Weekly stool collection, blood draws at Weeks 1, 4, 6, and 8

Follow-up

Participants are monitored for changes in inflammatory markers and gut microbiome composition.

4 weeks

Blood draws and stool samples collected at Weeks 6 and 8

Optional Long-term Follow-up

Optional follow-ups at 1, 3, and 5 years to assess polyp recurrence.

Treatment Details

Interventions

• Modified Plant-Based Mediterranean Diet

Trial Overview The study tests how a modified plant-based Mediterranean diet affects the gut microbiome, immune system, and metabolism after a colonoscopy. Researchers will analyze stool DNA, blood serum, and metabolic changes to understand the diet's impact on health.

Participant Groups

Group I: Dietary Intervention Group Experimental Treatment 1 Intervention

Participants in this arm will follow a modified plant-based Mediterranean diet following their colonoscopies. The dietary intervention aims to reduce inflammation and improve gut microbiome composition. Participants' gut bacteria and overall health will be monitored through blood and stool sample collections, focusing on inflammation reduction and metabolic health improvement.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Seerave Foundation

Collaborator

Trials

1

Recruited

30+

Findings from Research

In a study of 153 patients with ulcerative colitis after pouch surgery, adherence to the Mediterranean diet (MED) was linked to lower levels of fecal calprotectin, a marker of intestinal inflammation, suggesting that MED may help reduce inflammation in inflammatory bowel diseases.

Patients with normal pouch function who adhered more closely to the MED showed a trend towards a lower risk of developing pouchitis over an 8-year follow-up, indicating potential long-term benefits of the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet is associated with decreased fecal calprotectin in patients with ulcerative colitis after pouch surgery. Godny, L., Reshef, L., Pfeffer-Gik, T., et al.[2021]

In a study of 83,147 participants over 17 years, higher adherence to a modified Mediterranean diet was linked to a significantly lower risk of developing Crohn's disease (CD), with a hazard ratio of 0.42 for those with the highest adherence compared to the lowest.

No significant association was found between Mediterranean diet adherence and the risk of ulcerative colitis (UC), suggesting that the diet may specifically benefit those at risk for CD rather than UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean diet is associated with a lower risk of later-onset Crohn's disease: results from two large prospective cohort studies. Khalili, H., Håkansson, N., Chan, SS., et al.[2021]

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]

In a pilot study involving 26 individuals with Familial Adenomatous Polyposis (FAP), adherence to a low-inflammatory Mediterranean diet led to a significant reduction in the number of diarrheal discharges (p-value: 0.008).

Participants also showed improved dietary habits, significantly reducing the intake of not recommended foods (p-value: 0.002) and increasing the consumption of recommended foods (p-value: 0.075), indicating good adherence to the dietary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Dietary Habits and Diarrhea in Fap Individuals: A Mediterranean Low-Inflammatory Dietary Intervention. Maura, CC., Eleonora, B., Andreina, O., et al.[2021]

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]

In a 12-week study involving adults with quiescent ulcerative colitis, the Mediterranean Diet Pattern (MDP) significantly reduced inflammation, as indicated by lower levels of faecal calprotectin compared to the Canadian Habitual Diet Pattern (CHD).

The MDP also promoted beneficial changes in the gut microbiome, increasing levels of short-chain fatty acids and specific microbial species that may help protect against colitis, suggesting it could be an effective maintenance diet for patients in remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean Diet Pattern Improves Intestinal Inflammation Concomitant with Reshaping of the Bacteriome in Ulcerative Colitis: A Randomised Controlled Trial. Haskey, N., Estaki, M., Ye, J., et al.[2023]

A pilot study involving 34 patients with familial adenomatous polyposis (FAP) showed that following a low-inflammatory Mediterranean diet for 3 months led to improved dietary habits and increased consumption of healthy foods like vegetables and fish.

Participants experienced a reduction in gastrointestinal symptoms, such as fewer diarrheal discharges, indicating that the dietary intervention may help reduce inflammation and improve quality of life for FAP patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Low-Inflammatory Dietary Intervention to Reduce Inflammation and Improve Quality of Life in Patients With Familial Adenomatous Polyposis: Protocol Description and Preliminary Results. Pasanisi, P., Gariboldi, M., Verderio, P., et al.[2020]

Higher adherence to the Mediterranean Diet Score (MDS) is linked to an 8-54% lower risk of colorectal cancer (CRC), while higher Healthy Eating Index (HEI) scores are associated with a 20-56% lower risk, based on a systematic review of 12 studies involving case-control and prospective cohort designs.

Conversely, diets with higher pro-inflammatory scores, as measured by the Dietary Inflammatory Index (DII), are associated with a 12-65% increased risk of CRC, highlighting the importance of diet quality in cancer risk management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Index-based dietary patterns and colorectal cancer risk: a systematic review. Steck, SE., Guinter, M., Zheng, J., et al.[2023]

The Mediterranean diet (MD) is associated with a gut microbiota that promotes an anti-inflammatory environment, which may help prevent colorectal cancer (CRC) and inflammatory bowel diseases (IBD).

In contrast, patients with CRC and IBD have a microbiota profile that is enriched in pro-inflammatory bacteria, suggesting that adopting MD could be a beneficial lifestyle change to improve gut health and reduce disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean Diet to Prevent the Development of Colon Diseases: A Meta-Analysis of Gut Microbiota Studies. Illescas, O., Rodríguez-Sosa, M., Gariboldi, M.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Adherence to the Mediterranean diet is associated with decreased fecal calprotectin in patients with ulcerative colitis after pouch surgery. [2021]

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

Adherence to a Mediterranean diet is associated with a lower risk of later-onset Crohn's disease: results from two large prospective cohort studies. [2021]

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

Diet in Treatment of Inflammatory Bowel Diseases. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Dietary Habits and Diarrhea in Fap Individuals: A Mediterranean Low-Inflammatory Dietary Intervention. [2021]

5. New Zealand 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. [2022]

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

A Mediterranean Diet Pattern Improves Intestinal Inflammation Concomitant with Reshaping of the Bacteriome in Ulcerative Colitis: A Randomised Controlled Trial. [2023]

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

A Pilot Low-Inflammatory Dietary Intervention to Reduce Inflammation and Improve Quality of Life in Patients With Familial Adenomatous Polyposis: Protocol Description and Preliminary Results. [2020]

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

Index-based dietary patterns and colorectal cancer risk: a systematic review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Mediterranean Diet to Prevent the Development of Colon Diseases: A Meta-Analysis of Gut Microbiota Studies. [2021]