Clinical trial NCT03994432: Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis
Official title: Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Keywords: mediterranean diet
endometriosis
physical activity
7 minutes work-out
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.

Detailed description: Endometriosis is an estrogen-dependent inflammatory disease, affecting almost 5% of the female population during the reproductive period. The most common symptom of women with endometriosis is dysmenorrhea. Nowadays, the main therapy is pharmacological treatment (estrogen-progestins and progestins); diet and physical exercises may represent a complementary and feasible approach to reduce the pain symptoms related to this disease.

Indeed, diet may be involved in several pathophysiological mechanisms linked to endometriosis, due to its ability to influence positively or negatively prostaglandins' metabolism, chronic inflammatory processes and circulating estrogen levels.

Among the various dietary regimes, the Mediterranean diet shows many anti-inflammatory and anti-oxidant properties.

Also regular physical activity can affect positively endometriosis, due to various etiopathogenetic mechanisms including the decrease of estrogenic levels and ovulatory frequency, the increase in SHBG levels, and the modulation of cytokines in an anti-inflammatory way.

One of the reasons of low regular physical activity is the lack of free time. For this reason, the American College of Sports Medicine developed a program designed for most of the population, called "7-minutes workout". It consists in 12 high-intensity physical exercises, lasting 30 seconds each and spaced out 10 seconds of short breaks, to be performed 2-3 times a week.

Currently, there are few studies evaluating the impact of regular physical activity and Mediterranean diet regimen on endometriosis.

The objective of this randomized controlled trial is to evaluate the potential beneficial impact of regular aerobic physical activity and Mediterranean diet on endometriosis pain symptoms.

Eligible women will be selected among those attending the Endometriosis Clinic of the "L. Mangiagalli ", IRCCS Ca 'Granda Foundation and Ospedale Maggiore Policlinico, and will be randomized into two homogeneous groups ("intervention" and "control") with a 1:1 ratio, according to the type of therapy: estro-progestins or progestins.

The "intervention" group will be composed of women with symptomatic endometriosis in estro-progestins or only progestin therapy, who will be asked to follow a Mediterranean diet and to practice a regular exercise program according to the "7-minutes workout" model. The "control" group will be composed of women with symptomatic endometriosis under therapy with estro-progestins or progestins who will continue to receive the routine clinical care.

All patients participating in the study will undergo clinical and ultrasonographic evaluation every fourth months. On these occasions, women will be routinely asked to complete some questionnaires, one on pain (a numerical rating scale, NRS), one on quality of life (the Short Form-12 questionnaire, SF-12), one on psychological status (the Hospital Anxiety and Depression scale, HADS), one on sexual functioning (theFemale Sexual Function Index, FSFI) and one on the global impression of change (Patients' Global Impression of Change scale, PGIC). Women will be also asked to rate the degree of satisfaction with their treatment. Moreover, at the beginning and at the end of the study all participants will be asked to complete a dietary questionnaire, a physical activity questionnaire (International Physical Activity Questionnaire, IPAQ) and a sleep quality questionnaire (The Pittsburgh Sleep Quality Index, PSQI).

Only the patients in the "intervention" group will be asked to follow a Mediterranean diet. They will receive a nutritional counseling with the investigator's hospital dietician periodically. Furthermore, these patients will follow an aerobic physical activity program 2-3 times a week for one year.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 45 years
* body mass index between 18 and 29.9
* women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
* not seeking conception

Exclusion Criteria:

* associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
* patients in note for all kind of surgery
* women who conduct a strong physical activity.
* women who follow vegetarian-vegan diet regimens.
* metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
* medical contraindications to proposed physical activity.

Primary outcomes:
measure: Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
timeFrame: 12 months
Secondary outcomes:
measure: The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
timeFrame: 12 months
measure: Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity
timeFrame: 12 months
measure: Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
timeFrame: 12 months
measure: Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
timeFrame: 12 months
measure: Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Laura Buggio Centro Endometriosi e Metrorragie Clinica Mangiagalli, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Study officials:
References: