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

24 Participants Needed

Trial Summary

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 data supports the effectiveness of the Mediterranean Diet as a treatment for endometriosis?

Research suggests that the Mediterranean Diet may help reduce pain perception in endometriosis by addressing oxidative stress (damage caused by free radicals in the body). Additionally, dietary changes, including adopting the Mediterranean Diet, have shown potential benefits in managing symptoms of chronic inflammatory conditions like endometriosis. ^{1 2 3 4 5}

Is the Mediterranean Diet safe for humans?

The Mediterranean Diet is generally considered safe for humans and has been associated with improved health markers, such as reduced cholesterol and increased vitamins and antioxidants, in women with endometriosis. ^{1 2 3 6 7}

How does the Mediterranean Diet treatment differ from other treatments for endometriosis?

The Mediterranean Diet treatment for endometriosis is unique because it focuses on dietary changes to reduce inflammation and oxidative stress, which are linked to pain and disease progression. Unlike pharmaceutical treatments that may have side effects, this diet emphasizes consuming foods rich in omega-3s, vitamins, and antioxidants, which can improve overall health and potentially alleviate symptoms. ^{2 7 8 9 10}

What is the purpose of this trial?

This study aims to test if making changes to diet can affect the pelvic pain associated with endometriosis. One group will follow a Mediterranean diet for 12 weeks while the control group will continue with their current diet. We will be looking at the feasibility of a larger-scale trial as well as self-reported quality of life and self-reported pain using standardized questionnaires, that have previously been used and validated, and assessing how this diet affects biomarkers associated with endometriosis and inflammation. Further, we will test how this change in diet affects the gut microbe flora.

Research Team

Mathew Leonardi, M.D.

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mediterranean Diet and Oxidative Stress: A Relationship with Pain Perception in Endometriosis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Diet and risk of endometriosis in a population-based case-control study. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

Different nutrient intake and prevalence of gastrointestinal comorbidities in women with endometriosis. [2020]

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

Effectiveness of Dietary Interventions in the Treatment of Endometriosis: a Systematic Review. [2023]

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

Food groups and nutrients consumption and risk of endometriosis: a systematic review and meta-analysis of observational studies. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Atherosclerosis and Endometriosis: The Role of Diet and Oxidative Stress in a Gender-Specific Disorder. [2023]

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

Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

Nutritional aspects related to endometriosis. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Diet quality and perceived effects of dietary changes in Dutch endometriosis patients: an observational study. [2022]