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Active Not Recruiting NCT05175248

Nutritional Intervention for Endometriosis

Conditions: Endometriosis

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Physicians Committee for Responsible Medicine

Location: Physicians Committee for Responsible Medicine Washington D.C. District of Columbia

Summary

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

Inclusion Criteria: 1. Women with a surgical, imaging, or clinical diagnosis of endometriosis 2. Age 18-45 years 3. Stable health condition and medications for past 3 months 4. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9 5. Able to follow a plant-based diet for 12 weeks 6. 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 Exclusion Criteria: 1. Body mass index ≥ 40 kg/m2 2. Smoking or drug abuse during the past six months 3. 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 4. Unstable medical or psychiatric illness 5. Already following a plant-based diet 6. Pregnant or breastfeeding, or plans of pregnancy within the study period 7. Hysterectomy or ovariectomy 8. Fibroids, ovarian cysts, pelvic inflammatory disease 9. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease 10. Lack of English fluency 11. Unable or unwilling to participate in all components of the study 12. Evidence of an eating disorder

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05175248). StuddyBuddy aggregates publicly available trial information.