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

McMaster University

Status: Invitation-only

Conditions: Endometriosis

Treatments: Behavioral: Diet Modification to Adopt Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05411549

McMaster - OBGYN - MDIE

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Mediterranean Diet

Experimental group

Description:

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

Treatment:

Behavioral: Diet Modification to Adopt Mediterranean Diet

No Diet Modification

No Intervention group

Description:

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