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

NCT05411549 | Enrolling By Invitation

• 1 other identifier: McMaster - OBGYN - MDIE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diet Modification; Anti-Inflammatory Diet; Endometriosis Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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).

  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)

  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)

  1 Year

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

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

No Diet Modification

NO 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

Interventions

Diet Modification to Adopt Mediterranean Diet BEHAVIORAL

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.

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mathew Leonardi, M.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data is de-identified upon collection, Lab teams will not be aware of arm allocation, nor will the participants be aware of the opposite group of which they are enrolled. However, due to the nature of this study, masking of the clinical team and participant is not feasible in order for diet changes to occur safely.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 Arm Interventional Diet Modification Study Arm 1: Mediterranean Diet Counselling (Intervention) Arm 2: Continue Normal Diet (Control)

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: June 9, 2022
• Study Start: August 22, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)