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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Endometriosis
• Intervention / Treatment: Behavioral: Diet Modification to Adopt Mediterranean Diet

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identified female at birth
• aged 18-45
• diagnosed with endometriosis (radiologically (ultrasound or magnetic resonance imaging (MRI)) or surgically confirmed diagnosis of endometriosis)
• Able and willing to provide written consent to participate in the study.

Exclusion Criteria:

• History of or diagnosis of gynecologic or GI malignancy
• Post-menopausal
• Currently pregnant or lactating
• Dietary restrictions due to medical conditions (e.g., Celiac disease, allergies)
• People who are already following a formal anti-inflammatory diet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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	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.
No Intervention: No Diet Modification; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a large multi-site trial measured by assessing enrolment rate, dropout rate, time to sample size, adherence (Mediterranean Diet Adherence Score), time for intervention group to follow diet, food costs and frequency/type of Adverse Events.	Dropout rate, time it takes to reach our sample size (24), adherence to the intervention using the Mediterranean Diet Adherence Score, the time it takes for study intervention group to be subjectively following the Mediterranean diet regularly, cost of food throughout the study, and frequency and type of Adverse Eventss will be measured using a case report form at each study visit.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If the Mediterranean Diet improves pain of patients with endometriosis assessed using a visual analog scale (VAS) as well as the Endometriosis Health Profile (EHP-30).	The VAS is measured on a 1 - 10 scale with 1 representing no pain and 10 representing life-debilitating pain. The EHP-30 is measured on a standardized scale from 0 to 100 where 0 represents the best health and 100 represents the worst health.	1 Year
To assess whether the Mediterranean Diet can improve the concentration of peripheral inflammatory markers from baseline to study-end assessed using a 71 inflammatory marker protein array (EveTechnologies, Calgary, AB)	Collection occurring at baseline and final visits	1 Year
To assess if there is a change in the composition of the microbiota following a dietary change to the Mediterranean Diet using 16s ribosomal ribonucleic acid sequencing (McMaster Genomic Facility)	Collection occurring at baseline and final visits	1 Year

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Mathew Leonardi, M.D., McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Diet Modification; Anti-Inflammatory Diet; Endometriosis Diet
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: McMaster - OBGYN - MDIE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Identifiable information will be shared outside of the direct study team (clinical team, research coordinator). De-identification of all collected information will occur during collection as to not save personal identifiers in our database.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No