The Role of a Mediterranean Diet in Patients With Endometriosis: a Feasibility Trial
- Conditions
- Endometriosis
- Interventions
- Behavioral: Diet Modification to Adopt Mediterranean Diet
- Registration Number
- NCT05411549
- Lead Sponsor
- McMaster University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 24
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediterranean Diet 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 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
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method 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 Collection occurring at baseline and final visits
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 Collection occurring at baseline and final visits
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 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.
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada