Estudio de la Influencia de la Dieta mediterránea en la Calidad de Vida de Las Pacientes Con Endometriosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Quality of life and endometriosis.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Quality of life and endometriosis.
时间窗: 24 weeks
Endometriosis Health Profile 30 (EHP-30) questionnaire (0-100)
Pain intensity in symptoms related to endometriosis
时间窗: 24 weeks
Pain with menstruation or Dysmenorrhea - A numeric scale (0-10)
次要结局
- General Quality of Life(24 weeks)
- Use of analgesics(24 weeks)
- Change in BMI(24 weeks)
- Diet quality(24 weeks)
- Adherence to the Mediterranean diet(24 weeks)
- Satisfaction Survey(24 weeks)