Endometriosis
Conditions
Keywords
Endometriosis, Mediterranean diet, Quality of life
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.
Interventions
OTHERDiet 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.
Sponsors
Biogipuzkoa Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and endometriosis. | 24 weeks | Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100) |
| Pain intensity in symptoms related to endometriosis | 24 weeks | Pain with menstruation or Dysmenorrhea - A numeric scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of analgesics | 24 weeks | Collecting the use of analgesics. |
| General Quality of Life | 24 weeks | WHOQOL-BREF questionnaire. (0-100) |
| Change in BMI | 24 weeks | Abdominal and hip circumference. (cm) |
| Diet quality | 24 weeks | Diet Quality Assessment Survey developed by the Spanish Society of Dietetics and Food Sciences (SEDCA). |
| Adherence to the Mediterranean diet | 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). |
| Satisfaction Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Medical history related to endometriosis | 24 weeks | Type of endometriosis (Not reported/ Ovarian endometriosis/ Deep endometriosis/ Endometriosis) |
| Current situation related to endometriosis | 24 weeks | Symptoms. |
| Physical examination | 24 weeks | Weight (kg) |
| Personal data | 24 weeks | Date and place of birth. |
| Obstetric history | 24 weeks | Assisted reproduction treatments (Current/completed/future) |
Countries
Spain
Contacts
Primary ContactJone Paredes Goenaga JONE.PAREDESGOENAGA@osakidetza.eus, Ginecology and Obstetrics
Outcome results
None listed