Hospital Universitario Donostia (HUD)
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
NCT Number: NCT07270393
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24 weeks
Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)
Time frame: 24 weeks
Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)
Time frame: 24 weeks
Pain with sexual intercourse or Dyspareunia - A numeric scale (0-10)
Time frame: 24 weeks
Pain with defecation or Dyschezia - A numeric scale (0-10)
Time frame: 24 weeks
Pain with urination or Dysuria - A numeric scale (0-10)
Time frame: 24 weeks
Non-menstrual pelvic pain - A numeric scale (0-10)
Time frame: 24 weeks
Abdominal bloating or distension - A numeric scale (0-10)
Time frame: 24 weeks
Tiredness - A numeric scale (0-10)
Time frame: 24 weeks
WHOQOL-BREF questionnaire. (0-100)
Time frame: 24 weeks
Collecting the use of analgesics.
Time frame: 24 weeks
Abdominal and hip circumference. (cm)
Time frame: 24 weeks
Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA).
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).
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.
Time frame: 24 weeks
Date and place of birth.
Time frame: 24 weeks
Number of children.
Time frame: 24 weeks
Weight (kg)
Time frame: 24 weeks
Height (cm)
Time frame: 24 weeks
Body Mass Index (BMI) (kg/m2)
Time frame: 24 weeks
Abdominal circumference. (cm)
Time frame: 24 weeks
Hip circumference (cm)
Time frame: 24 weeks
Assisted reproduction treatments (Current/completed/future)
Time frame: 24 weeks
Gestational desire
Time frame: 24 weeks
Type of endometriosis (Not reported/ Ovarian endometriosis/ Deep endometriosis/ Endometriosis)
Time frame: 24 weeks
Diagnosis of endometriosis by: radiology and/or surgery.
Time frame: 24 weeks
Previous diets performed.
Time frame: 24 weeks
Treatments received: Medical (hormonal contraception, analogues, other).
Time frame: 24 weeks
Treatments received: Surgical (conservative vs. radical surgery).
Time frame: 24 weeks
Symptoms.
Time frame: 24 weeks
Current treatment.
Time frame: 24 weeks
Diagnosis: Date- time of evolution since onset of symptom.
Contact information is provided by the study sponsor or research team.
Jone Paredes Goenaga [email protected], Ginecology and Obstetrics
CONTACT
Biogipuzkoa Health Research Institute
Other
Estudio de la Influencia de la Dieta mediterránea en la Calidad de Vida de Las Pacientes Con Endometriosis.
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