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

NCT07270393 | Not Yet Recruiting DMC

• 1 other identifier: PAR-DON-2024-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

Endometriosis; Mediterranean diet; Quality of life

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• General Quality of Life

  24 weeks

• Use of analgesics

  24 weeks

• Change in BMI

  24 weeks

• Diet quality

  24 weeks

• Adherence to the Mediterranean diet

  24 weeks

Other Outcomes (17)

• Personal data

  24 weeks

• Personal data

  24 weeks

• Physical examination

  24 weeks

Study Arms (2)

Control Group

NO INTERVENTION

This group will not receive normocaloric Mediterranean diet recommendations.

Intervention Group

EXPERIMENTAL

This group will receive a series of normocaloric Mediterranean diet recommendations.

Other: Diet supplementation

Interventions

Diet supplementation OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (1)

Hospital Universitario Donostia (HUD)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics

CONTACT

943007478; JONE.PAREDESGOENAGA@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-03

Locations

ES (1)