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Not yet recruiting NCT07270393

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

No phase Interventional Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet supplementation.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Quality of life and endometriosis. [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
  • Pain intensity in symptoms related to endometriosis [Time frame: 24 weeks]
Secondary outcome measures (6)
  • General Quality of Life [Time frame: 24 weeks]
  • Use of analgesics [Time frame: 24 weeks]
  • Change in BMI [Time frame: 24 weeks]
  • Diet quality [Time frame: 24 weeks]
  • Adherence to the Mediterranean diet [Time frame: 24 weeks]
  • Satisfaction Survey [Time frame: 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Hospital Universitario Donostia (HUD) — Donostia / San Sebastian

Identifiers

NCT: NCT07270393 · PAR-DON-2024-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗