Mediterranean Diet for Endometriosis

(MDIE Trial)

Overseen By Mathew Leonardi, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Gynecologic malignancy, GI malignancy, Post-menopausal, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Mediterranean diet can reduce pelvic pain in individuals with endometriosis. Participants will be divided into two groups: one will follow the Mediterranean diet for 12 weeks, and the other will maintain their usual eating habits. Researchers aim to determine if dietary changes improve pain, quality of life, and gut health. Women diagnosed with endometriosis who aren't already following a special diet may be suitable for this study. As an unphased study, this trial provides a unique opportunity to contribute to understanding how dietary changes might alleviate endometriosis symptoms.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on dietary changes, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this diet modification is safe for participants?

Research has shown that following a Mediterranean diet is safe and may alleviate endometriosis symptoms. This diet emphasizes fruits, vegetables, fish, and other healthy foods. Studies have found that individuals who adhere closely to the Mediterranean diet have a 94% lower risk of developing endometriosis. Specifically, one study found that 72% of participants with endometriosis experienced more than a 50% improvement in symptoms after just four weeks on this diet.

These findings suggest that the Mediterranean diet is not only safe but also potentially beneficial for those with endometriosis. Overall, this diet is considered healthy and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about adopting the Mediterranean diet for endometriosis because it offers a non-invasive, lifestyle-based approach that could potentially reduce symptoms and improve quality of life. Unlike standard treatments, such as hormonal therapies and pain relievers, which can have significant side effects, a Mediterranean diet focuses on whole foods like fruits, vegetables, whole grains, and healthy fats. This diet may help by naturally reducing inflammation and supporting gut health, addressing the condition from a dietary angle rather than relying solely on medication. This unique approach could offer a complementary or alternative option for those looking for more holistic management of endometriosis.

What evidence suggests that adopting a Mediterranean diet might be an effective treatment for endometriosis?

Research has shown that the Mediterranean diet might help reduce symptoms of endometriosis. In one study, following this diet was linked to a 94% lower chance of having the condition. Another study found that 72% of patients experienced more than a 50% improvement in symptoms after just four weeks on this diet. In this trial, participants in one arm will adopt a Mediterranean diet for a 12-week period. Eating plenty of fruits, vegetables, fish, and meat may help with endometriosis symptoms, possibly due to its anti-inflammatory effects. These findings suggest that adopting a Mediterranean diet could be beneficial for those experiencing endometriosis-related pelvic pain. ^{1 2 3 5 6}

Who Is on the Research Team?

Mathew Leonardi, M.D.

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for individuals assigned female at birth, aged 18-45, who have been diagnosed with endometriosis either through ultrasound or MRI, or confirmed surgically. Participants must be able to give written consent.

Inclusion Criteria

Able and willing to provide written consent to participate in the study.

I was identified as female at birth.

My endometriosis was confirmed by ultrasound, MRI, or surgery.

Exclusion Criteria

People who are already following a formal anti-inflammatory diet.

I have or had cancer in my reproductive or digestive system.

Currently pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a Mediterranean diet for 12 weeks or continue their current diet

12 weeks

Baseline and final visit (in-person)

Follow-up

Participants are monitored for changes in inflammatory markers, microbiota composition, and pain levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet Modification to Adopt Mediterranean Diet

Trial Overview

The study is examining the impact of a Mediterranean diet on pelvic pain and quality of life in patients with endometriosis over a period of 12 weeks. It will compare results between those following this diet and those maintaining their usual diet.

How Is the Trial Designed?

Group I: Mediterranean Diet Experimental Treatment 1 Intervention

Participants enrolled in group 1 will be counselled by a dietician and asked to adopt a Mediterranean diet for a 12-week period from counselling. Participants will complete the Mediterranean Diet Adherence Score, pain questionnaires as well as quality of life questionnaires (EPH-30, SF-36, GIQLI) which have been previously validated. Participants in this group will give a baseline and final visit blood sample and stool samples to assess inflammation biomarkers as well as gut microflora

Group II: No Diet Modification Active Control 1 Intervention

Participants enrolled in group 2 will be NOT counselled by a dietician. Participants will complete the Mediterranean Diet Adherence Score, pain questionnaires as well as quality of life questionnaires (EPH-30, SF-36, GIQLI) which have been previously validated. Participants in this group will give a baseline and final visit blood sample and stool samples to assess inflammation biomarkers as well as gut microflora

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Published Research Related to This Trial

In a study of 284 women with endometriosis and 660 controls, higher total fat consumption was linked to a decreased risk of developing endometriosis, suggesting that dietary fat may play a protective role.

Conversely, increased intake of β-carotene and higher fruit consumption were associated with a higher risk of endometriosis, indicating that certain dietary components may contribute to the disease's development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and risk of endometriosis in a population-based case-control study. Trabert, B., Peters, U., De Roos, AJ., et al.[2021]

Nutritional deficiencies can lead to changes in lipid metabolism and oxidative stress, which may contribute to the development and progression of endometriosis.

Diets rich in omega-3 fatty acids, along with supplements like N-acetylcysteine, vitamin D, and resveratrol, as well as increased intake of fruits, vegetables, and whole grains, may help reduce the risk of endometriosis and support its regression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional aspects related to endometriosis. Halpern, G., Schor, E., Kopelman, A.[2016]

A systematic review identified 21 studies (9 human and 12 animal) on dietary interventions for endometriosis, with most reporting positive effects on symptoms, although many had moderate to high risk of bias.

The study highlights the need for more rigorous randomized controlled trials to better understand the effectiveness and safety of dietary modifications as a treatment for endometriosis, as current evidence is inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dietary Interventions in the Treatment of Endometriosis: a Systematic Review. Nirgianakis, K., Egger, K., Kalaitzopoulos, DR., et al.[2023]

Higher total dairy intake is associated with a decreased risk of endometriosis, with a relative risk of 0.90, indicating that consuming dairy may be protective against this condition.

Conversely, increased consumption of red meat, trans fatty acids, and saturated fatty acids is linked to a higher risk of endometriosis, with relative risks of 1.17, 1.12, and 1.06 respectively, suggesting that certain dietary fats may contribute to the development of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food groups and nutrients consumption and risk of endometriosis: a systematic review and meta-analysis of observational studies. Arab, A., Karimi, E., Vingrys, K., et al.[2022]

In a study of 157 women with endometriosis, participants reported making various dietary changes, with 46.5% following specific diets and 56.1% using dietary supplements, but overall, their diet quality was lower than that of a healthy reference group.

While dietary adjustments did not correlate with improved quality of life, many participants (71.3%) felt that these changes, particularly the removal of gluten, dairy, or soy, helped reduce pain-related symptoms of endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet quality and perceived effects of dietary changes in Dutch endometriosis patients: an observational study. Krabbenborg, I., de Roos, N., van der Grinten, P., et al.[2022]

A survey of 484 women with endometriosis revealed that 44% used dietary strategies for symptom management, with common approaches including reducing gluten, dairy, and following a low-FODMAP diet.

Participants reported an average effectiveness score of 6.4/10 for dietary changes in reducing pelvic pain, and significant improvements in gastrointestinal disturbances, nausea, and fatigue, indicating that dietary modifications can be a valuable self-management strategy for endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey. Armour, M., Middleton, A., Lim, S., et al.[2021]

Women with endometriosis who followed the endometriosis diet reported significantly better quality of life (QoL) across all six domains compared to those who did not adhere to the diet, based on a study of 211 participants.

Strict adherence to the diet led to even higher QoL scores than less strict adherence, suggesting that the diet may have a positive impact on the well-being of women with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A better quality of life could be achieved by applying the endometriosis diet: a cross-sectional study in Dutch endometriosis patients. van Haaps, A., Wijbers, J., Schreurs, A., et al.[2023]

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