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Enrolling by Invitation

NCT Number: NCT05411549

The Role of a Mediterranean Diet 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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 1 Year

    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.

Secondary outcomes

  1. 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).

    Time frame: 1 Year

    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.

  2. 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)

    Time frame: 1 Year

    Collection occurring at baseline and final visits

  3. 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)

    Time frame: 1 Year

    Collection occurring at baseline and final visits

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

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

Acronym: MDIE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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