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

Primary Purpose

Endometriosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet Modification to Adopt Mediterranean Diet
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring Diet Modification, Anti-Inflammatory Diet, Endometriosis Diet

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mediterranean Diet

    No Diet Modification

    Arm Description

    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

    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

    Outcomes

    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.
    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).
    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)
    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)
    Collection occurring at baseline and final visits

    Full Information

    First Posted
    March 28, 2022
    Last Updated
    March 22, 2023
    Sponsor
    McMaster University
    Collaborators
    Hamilton Health Sciences Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05411549
    Brief Title
    The Role of a Mediterranean Diet in Patients With Endometriosis: a Feasibility Trial
    Acronym
    MDIE
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    Hamilton Health Sciences Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometriosis
    Keywords
    Diet Modification, Anti-Inflammatory Diet, Endometriosis Diet

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 Arm Interventional Diet Modification Study Arm 1: Mediterranean Diet Counselling (Intervention) Arm 2: Continue Normal Diet (Control)
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mediterranean Diet
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    No Diet Modification
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet Modification to Adopt Mediterranean Diet
    Intervention Description
    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 Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    1 Year
    Secondary Outcome Measure Information:
    Title
    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).
    Description
    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.
    Time Frame
    1 Year
    Title
    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)
    Description
    Collection occurring at baseline and final visits
    Time Frame
    1 Year
    Title
    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)
    Description
    Collection occurring at baseline and final visits
    Time Frame
    1 Year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kyle McGowan, H.B.Sc
    Phone
    905-521-2100
    Ext
    21334
    Email
    mcgowank@mcmaster.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mathew Leonardi, M.D.
    Phone
    905-521-2100
    Ext
    76252
    Email
    leonam@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mathew Leonardi, M.D.
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No Identifiable information will be shared outside of the direct study team (clinical team, research coordinator). De-identification of all collected information will occur during collection as to not save personal identifiers in our databse.

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

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