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

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05411549

Collaborator

Hamilton Health Sciences Corporation (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Behavioral: Diet Modification to Adopt Mediterranean Diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: 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 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.
No Intervention: No Diet Modification 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

Arm

Intervention/Treatment

Experimental: 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

Behavioral: 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 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.

No Intervention: No Diet Modification

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

Outcome Measures

Primary Outcome Measures

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 AEs will be measured using a case report form at each study visit.

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McMaster University
Hamilton Health Sciences Corporation

Investigators

Principal Investigator: Mathew Leonardi, M.D., McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

McMaster University

ClinicalTrials.gov Identifier:

NCT05411549

Other Study ID Numbers:

McMaster - OBGYN - MDIE

First Posted:

Jun 9, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by McMaster University

Diet Modification

Anti-Inflammatory Diet

Endometriosis Diet

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jun 9, 2022