A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis (NCT07090096) | Clinical Trial Compass
RecruitingNot Applicable
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
United States120 participantsStarted 2025-11-01
Plain-language summary
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study visits, procedures, requirements, and availability for the duration of the study
✓. Women with a surgical, imaging, or clinical diagnosis of endometriosis
✓. Age 18-45 years
✓. Stable health condition and medications for the past 3 months
✓. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9
✓. Willing to be randomly assigned to either an active or a control group
✓. Agreement to adhere to Lifestyle Considerations throughout the study duration
Exclusion criteria
✕. 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
✕. Already following a WFPB diet
✕. Pregnant or breastfeeding, or plans of pregnancy within the study period
✕. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease