Nutritional Intervention for Endometriosis
Running, not enrolling · Not applicable
Conditions studied: Endometriosis
In brief
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.
Key facts
- Study ID
- NCT05175248
- Run by
- Physicians Committee for Responsible Medicine
- People needed
- 120
- Starts
- 2022-03-02
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Able to follow a plant-based diet for 12 weeks
- Willing to be randomly assigned to either a plant-based group or a control group that will not make any dietary changes for 12 weeks
You may not qualify if…
- 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
- Already following a plant-based diet
- Pregnant or breastfeeding, or plans of pregnancy within the study period
- Hysterectomy or ovariectomy
- Fibroids, ovarian cysts, pelvic inflammatory disease
- Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease
- Lack of English fluency
- Unable or unwilling to participate in all components of the study
- Evidence of an eating disorder
Where it is running
- Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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