Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis (NCT03994432) | Clinical Trial Compass
CompletedNot Applicable
Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis
Italy140 participantsStarted 2019-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Timeframe: 12 months
Trial details
NCT IDNCT03994432
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico