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NCT Number: NCT07270393

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Donostia (HUD)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Quality of life and endometriosis.

    Time frame: 24 weeks

    Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)

  2. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)

  3. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)

  4. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Pain with defecation or Dyschezia - A numeric scale (0-10)

  5. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Pain with urination or Dysuria - A numeric scale (0-10)

  6. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Non-menstrual pelvic pain - A numeric scale (0-10)

  7. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Abdominal bloating or distension - A numeric scale (0-10)

  8. Pain intensity in symptoms related to endometriosis

    Time frame: 24 weeks

    Tiredness - A numeric scale (0-10)

Secondary outcomes

  1. General Quality of Life

    Time frame: 24 weeks

    WHOQOL-BREF questionnaire. (0-100)

  2. Use of analgesics

    Time frame: 24 weeks

    Collecting the use of analgesics.

  3. Change in BMI

    Time frame: 24 weeks

    Abdominal and hip circumference. (cm)

  4. Diet quality

    Time frame: 24 weeks

    Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA).

  5. Adherence to the Mediterranean diet

    Time frame: 24 weeks

    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).

  6. Satisfaction Survey

    Time frame: 24 weeks

    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.

Other outcomes

  1. Personal data

    Time frame: 24 weeks

    Date and place of birth.

  2. Personal data

    Time frame: 24 weeks

    Number of children.

  3. Physical examination

    Time frame: 24 weeks

    Weight (kg)

  4. Physical examination

    Time frame: 24 weeks

    Height (cm)

  5. Physical examination

    Time frame: 24 weeks

    Body Mass Index (BMI) (kg/m2)

  6. Physical examination

    Time frame: 24 weeks

    Abdominal circumference. (cm)

  7. Physical examination

    Time frame: 24 weeks

    Hip circumference (cm)

  8. Obstetric history

    Time frame: 24 weeks

    Assisted reproduction treatments (Current/completed/future)

  9. Obstetric history

    Time frame: 24 weeks

    Gestational desire

  10. Medical history related to endometriosis

    Time frame: 24 weeks

    Type of endometriosis (Not reported/ Ovarian endometriosis/ Deep endometriosis/ Endometriosis)

  11. Medical history related to endometriosis

    Time frame: 24 weeks

    Diagnosis of endometriosis by: radiology and/or surgery.

  12. Medical history related to endometriosis

    Time frame: 24 weeks

    Previous diets performed.

  13. Medical history related to endometriosis

    Time frame: 24 weeks

    Treatments received: Medical (hormonal contraception, analogues, other).

  14. Medical history related to endometriosis

    Time frame: 24 weeks

    Treatments received: Surgical (conservative vs. radical surgery).

  15. Current situation related to endometriosis

    Time frame: 24 weeks

    Symptoms.

  16. Current situation related to endometriosis

    Time frame: 24 weeks

    Current treatment.

  17. Medical history related to endometriosis

    Time frame: 24 weeks

    Diagnosis: Date- time of evolution since onset of symptom.

Study contacts

Contact information is provided by the study sponsor or research team.

Jone Paredes Goenaga [email protected], Ginecology and Obstetrics

CONTACT

[email protected]

943007478

Sponsors and collaborators

Lead sponsor

Biogipuzkoa Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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