Clinical trial NCT05411549: The Role of a Mediterranean Diet in Patients With Endometriosis: a Feasibility Trial
Official title: The Role of a Mediterranean Diet in Long-term Management of Pelvic Pain in Patients With Endometriosis: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Endometriosis
Keywords: Diet Modification
Anti-Inflammatory Diet
Endometriosis Diet
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2022-06-09
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 Arm Interventional Diet Modification Study Arm 1: Mediterranean Diet Counselling (Intervention) Arm 2: Continue Normal Diet (Control)
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 Year
Secondary outcomes:
measure: 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).
timeFrame: 1 Year
measure: 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)
timeFrame: 1 Year
measure: 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)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Mathew Leonardi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: