Study of the Influence of the Mediterranean Diet on the Quality of Life of Patients With Endometriosis.

Estudio de la Influencia de la Dieta mediterránea en la Calidad de Vida de Las Pacientes Con Endometriosis.

The severities of chronic disease symptoms correlate with the levels of analytical parameters of inflammation. Studies have been published in which the Mediterranean diet has an anti-inflammatory phenomenon, decreasing inflammation parameters. This decrease correlates with an improvement in symptoms.

Endometriosis is a chronic inflammatory disease and the influence of the Mediterranean diet on the decrease of inflammation parameters in women with endometriosis has been studied.

The studies carried out to assess whether this decrease in inflammatory parameters correlates with clinical improvement and quality of life in these patients have low/very low scientific evidence (small sample size, no control group) and with different interventions (diets, restrictions and/or supplements), which prevent their analysis as a whole.

Therefore, our hypothesis is that the Mediterranean diet, due to its anti-inflammatory effect, can improve the symptomatology and quality of life of patients with endometriosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: Diet supplementation

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics; Phone Number: 943007478; Email: JONE.PAREDESGOENAGA@osakidetza.eus

Study Locations

• Spain
  • Gipuzkoa
    • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
      • Hospital Universitario Donostia (HUD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

• Female.
• Age 18-45.
• Premenopausal status.
• Radiological diagnosis (by transvaginal ultrasound and/or MRI) and/or surgical diagnosis of endometriosis.
• Follow-up in the Gynecology Department of OSI Donostia (at least 1 visit in the last year).
• Clinical score of at least 3/10 on the Numerical Scale in at least one symptom related to endometriosis).
• Possibility of understanding Spanish.
• Possibility of understanding the indicated dietary recommendations.
• Acceptance of inclusion in clinical study, by signing informed consent.

EXCLUSION CRITERIA:

• Diagnosis of Eating Disorder.
• Diagnosis of malabsorptive syndromes: Chron's disease, Ulcerative colitis, short bowel syndrome, gastric by-pass, irritable bowel.
• Other concomitant diseases that produce CPD.
• Autoimmune diseases.-
• Metabolic diseases requiring follow-up of specific diets.
• Diagnosed gluten intolerance.
• Vegan diet.
• Follow-up by a nutritionist.
• Diagnosis of severe mental illness requiring treatment.
• Pregnancy or current breastfeeding.
• Active cancer process.
• Personal history of gynecologic or digestive oncologic process.
• Change of treatment or surgery during follow-up.
• Surgery related to endometriosis or change of treatment in the 6 weeks prior to enrollment in the study.
• Drug abuse. Opioid analgesia < 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; This group will not receive normocaloric Mediterranean diet recommendations.
Experimental: Intervention Group; This group will receive a series of normocaloric Mediterranean diet recommendations.	Other: Diet supplementation; The severities of chronic disease symptoms correlate with the levels of analytical parameters of inflammation. Studies have been published in which the Mediterranean diet has an anti-inflammatory phenomenon, decreasing inflammation parameters. This decrease correlates with an improvement in symptoms . Endometriosis is a chronic inflammatory disease and the influence of the Mediterranean diet on the decrease of inflammation parameters in women with endometriosis has been studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life and endometriosis.	Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)	24 weeks
Pain intensity in symptoms related to endometriosis	Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Pain with defecation or Dyschezia - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Pain with urination or Dysuria - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Non-menstrual pelvic pain - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Abdominal bloating or distension - A numeric scale (0-10)	24 weeks
Pain intensity in symptoms related to endometriosis	Tiredness - A numeric scale (0-10)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Quality of Life	WHOQOL-BREF questionnaire. (0-100)	24 weeks
Use of analgesics	Collecting the use of analgesics.	24 weeks
Change in BMI	Abdominal and hip circumference. (cm)	24 weeks
Diet quality	Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA).	24 weeks
Adherence to the Mediterranean diet	Diet adherence test, used in the PREDIMED study, available free of charge on the website of the Spanish Society of Dietetics and Food Sciences (SEDCA).	24 weeks
Satisfaction Survey	Brief questionnaire that seeks to know the patient's opinion about his or her experience and degree of satisfaction with different aspects of the study.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal data	Date and place of birth.	24 weeks
Personal data	Number of children.	24 weeks
Physical examination	Weight (kg)	24 weeks
Physical examination	Height (cm)	24 weeks
Physical examination	Body Mass Index (BMI) (kg/m2)	24 weeks
Physical examination	Abdominal circumference. (cm)	24 weeks
Physical examination	Hip circumference (cm)	24 weeks
Obstetric history	Assisted reproduction treatments (Current/completed/future)	24 weeks
Obstetric history	Gestational desire	24 weeks
Medical history related to endometriosis	Type of endometriosis (Not reported/ Ovarian endometriosis/ Deep endometriosis/ Endometriosis)	24 weeks
Medical history related to endometriosis	Diagnosis of endometriosis by: radiology and/or surgery.	24 weeks
Medical history related to endometriosis	Previous diets performed.	24 weeks
Medical history related to endometriosis	Treatments received: Medical (hormonal contraception, analogues, other).	24 weeks
Medical history related to endometriosis	Treatments received: Surgical (conservative vs. radical surgery).	24 weeks
Current situation related to endometriosis	Symptoms.	24 weeks
Current situation related to endometriosis	Current treatment.	24 weeks
Medical history related to endometriosis	Diagnosis: Date- time of evolution since onset of symptom.	24 weeks

Collaborators and Investigators

• Sponsor: Biogipuzkoa Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Endometriosis; Mediterranean diet
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: PAR-DON-2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No