Mediterranean Diet for Endometriosis
(MDIE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMathew Leonardi, M.D.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Trial Summary

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.

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.

+1 more

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

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Mediterranean DietExperimental Treatment1 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 ModificationActive Control1 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