NCT05411549

The Role of a Mediterranean Diet in Patients With Endometriosis: a Feasibility Trial

The Role of a Mediterranean Diet in Long-term Management of Pelvic Pain in Patients With Endometriosis: a Feasibility Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endometriosis

Interventions

Type	Name	Description
BEHAVIORAL	Diet Modification to Adopt Mediterranean Diet	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 a series of 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.

Timeline

• Start date: 2023-08-22
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-06-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: Canada