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

NCT ID: NCT07270393

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

This group will not receive normocaloric Mediterranean diet recommendations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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

Group Type: EXPERIMENTAL

Diet supplementation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biogipuzkoa Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Donostia (HUD)

Donostia / San Sebastian, Gipuzkoa, Spain

Countries

Spain

Central Contacts

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

Role: CONTACT

JONE.PAREDESGOENAGA@osakidetza.eus

943007478

Other Identifiers

PAR-DON-2024-01

Identifier Type: -

Identifier Source: org_study_id