Nutritional Intervention for Endometriosis
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPhysicians Committee for Responsible Medicine
About this trial
In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.
Eligibility criteria
Qualifiers
Women with a surgical, imaging, or clinical diagnosis of endometriosis
Age 18-45 years
Stable health condition and medications for past 3 months
Modified Biberoglu and Behrman (B&B) pelvic pain score of at least 5/9
Disqualifiers
Body mass index ≥ 40 kg/m2
Smoking or drug abuse during the past six months
Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
Unstable medical or psychiatric illness
Trial design
Treatments tested in this trial
- Plant-based Intervention Group
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov