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

ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBiogipuzkoa Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female.

Age 18-45.

Premenopausal status.

Radiological diagnosis (by transvaginal ultrasound and/or MRI) and/or surgical diagnosis of endometriosis.

Disqualifiers

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.-

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet supplementation

    Other intervention

    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.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of life and endometriosis.

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

Time frame
24 weeks
2

Pain intensity in symptoms related to endometriosis

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

Time frame
24 weeks
3

Pain intensity in symptoms related to endometriosis

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

Time frame
24 weeks
4

Pain intensity in symptoms related to endometriosis

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

Time frame
24 weeks

Secondary outcomes

1

General Quality of Life

WHOQOL-BREF questionnaire. (0-100)

Time frame
24 weeks
2

Use of analgesics

Collecting the use of analgesics.

Time frame
24 weeks
3

Change in BMI

Abdominal and hip circumference. (cm)

Time frame
24 weeks
4

Diet quality

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

Time frame
24 weeks

Other outcomes

1

Personal data

Date and place of birth.

Time frame
24 weeks
2

Personal data

Number of children.

Time frame
24 weeks
3

Physical examination

Weight (kg)

Time frame
24 weeks
4

Physical examination

Height (cm)

Time frame
24 weeks

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: