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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a modified plant-based Mediterranean diet can reduce inflammation and improve gut health after a colonoscopy. Researchers believe that certain healthy diets might positively change gut bacteria, enhancing overall well-being. They analyze stool and blood samples to study the effects on gut microorganisms and metabolism. Individuals who have had tubular, villous, or serrated polyps and are due for a second or third colonoscopy might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and gut health.

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 prior data suggests that this modified plant-based Mediterranean diet is safe?

Research shows that the Mediterranean diet is generally safe and easy to follow. Studies have found that people on this diet often experience improvements in gut health. For example, one study discovered that after following the Mediterranean diet for 8 weeks, participants had more beneficial gut bacteria, which was linked to reduced overall inflammation.

Another study found that the Mediterranean diet can help balance the microorganisms in the gut, promoting better health. These changes can lead to improved health without major side effects.

While specific safety data for the modified plant-based version of this diet is lacking, existing research suggests that the Mediterranean diet is a safe choice for improving gut health and reducing inflammation. Therefore, joining a trial focused on this diet is likely a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The modified plant-based Mediterranean diet is unique because it focuses on reducing inflammation and improving gut health through dietary changes rather than medications. Unlike standard treatments for inflammation, which often involve anti-inflammatory drugs or steroids, this approach uses natural foods rich in antioxidants and fibers to support a healthy gut microbiome. Researchers are excited about this diet because it could offer a more holistic and sustainable way to manage inflammation, potentially improving metabolic health without the side effects associated with traditional medications.

What evidence suggests that this modified plant-based Mediterranean diet is effective for reducing inflammation post-colonoscopy?

Research has shown that a Mediterranean diet can help reduce inflammation. Studies have found that it improves gut health by altering the mix of bacteria in the digestive system. This trial will test a modified plant-based Mediterranean diet as a dietary intervention for participants following their colonoscopies. This diet, rich in fruits, vegetables, and healthy fats, is linked to lower levels of substances in stool that indicate inflammation. It may also support better overall gut health and improve how the body uses and stores energy. These positive changes can enhance well-being, especially after procedures like colonoscopies. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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.

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

Citations

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Impact of Dietary Intervention on Inflammation and ... This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-8-2024-48927

Mediterranean Diet for Inflammation Post-Colonoscopy Trial Overview The study tests how a modified plant-based Mediterranean diet affects the gut microbiome, immune system, and metabolism after a colonoscopy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637046/

A Mediterranean Diet Pattern Improves Intestinal ... The results demonstrate that the MDP improved the faecal inflammatory biomarker FC, improved/maintained disease activity, altered the composition of the gut ...

4. gastrojournal.org gastrojournal.org/issue/S0016-5085(25)X6002-9?pageStart=26

May-May 2025 Sa1929: IMPACT OF PLANT- AND ANIMAL-BASED PROTEINS ON GUT MICROBIOME, METABOLISM, AND INFLAMMATION IN AGING MICE. Xing Kang,; Jenny Goh,; Levene W. Chua,; Sunny ...

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Microbiome-Mediated Effects of the Mediterranean Diet on ... Diets high in saturated fat and low in fiber contribute to metabolic endotoxemia through several mechanisms, including changes in the GI microbiome and ...

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Gut microbiome-Mediterranean diet interactions in improving ... The present perspective discusses the evidences that the Mediterranean diet induces gut microbiome modulation in rodents, non-human primates and human subjects.

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Mechanistic Implications of the Mediterranean Diet in ... The Mediterranean diet and consumption of its recommended dietary components correlated with improved microbial and metabolite composition.

8. mdpi.com mdpi.com/2072-6643/17/6/948

Gut Microbiota Modulation Through Mediterranean Diet ... After an 8-week intervention, researchers observed a significant increase in the genetic richness of the gut microbiome, associated with reduced systemic ...