EndometriosisNCT07270393
Study of the Influence of the Mediterranean Diet on the Quality of Life of Patients With Endometriosis.
A study testing Diet supplementation in people with Endometriosis, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Diet supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- Possibility of understanding Spanish.
- Possibility of understanding the indicated dietary recommendations.
- Acceptance of inclusion in clinical study, by signing informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics contact
Spain1 site
Hospital Universitario Donostia (HUD)
Donostia / San Sebastian, Gipuzkoa, 20014
About this study
Official title: 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.
Read more
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
- Being tested
- Diet supplementation
- Keywords
- Endometriosis, Mediterranean diet, Quality of life
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet supplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diet supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life and endometriosis.
Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Pain with defecation or Dyschezia - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Pain with urination or Dysuria - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Non-menstrual pelvic pain - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Abdominal bloating or distension - A numeric scale (0-10)
Measured: 24 weeks
Pain intensity in symptoms related to endometriosis
Tiredness - A numeric scale (0-10)
Measured: 24 weeks
Secondary outcomes (6)
General Quality of Life
WHOQOL-BREF questionnaire. (0-100)
Measured: 24 weeks
Use of analgesics
Collecting the use of analgesics.
Measured: 24 weeks
Change in BMI
Abdominal and hip circumference. (cm)
Measured: 24 weeks
Diet quality
Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA).
Measured: 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).
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270393
- Sponsor's protocol ID
- PAR-DON-2024-01
- Status last verified
- Mar 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio de la Influencia de la Dieta mediterránea en la Calidad de Vida de Las Pacientes Con Endometriosis.
- ClinicalTrials.gov ID
- NCT07270393
- Acronym / sponsor ID
- PAR-DON-2024-01
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Mediterranean diet, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will not receive normocaloric Mediterranean diet recommendations. |
| Intervention Group | Experimental | Other: Diet supplementationThis group will receive a series of normocaloric Mediterranean diet recommendations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet supplementationThe 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. | Other | Intervention Group |
Primary outcome
Quality of life and endometriosis.
Time frame: 24 weeks
Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Pain with defecation or Dyschezia - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Pain with urination or Dysuria - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Non-menstrual pelvic pain - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Abdominal bloating or distension - A numeric scale (0-10)
Pain intensity in symptoms related to endometriosis
Time frame: 24 weeks
Tiredness - A numeric scale (0-10)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet supplementation in people with Endometriosis, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics (943007478, JONE.PAREDESGOENAGA@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life and endometriosis. (time frame: 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.