A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Not Applicable

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT07090096
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

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. We want to see if this diet improves and pain and quality of life in women with endometriosis.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-10-01
• Primary Completion: 2028-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study visits, procedures, requirements, and availability for the duration of the study
3. Women with a surgical, imaging, or clinical diagnosis of endometriosis
4. Age 18-45 years
5. Stable health condition and medications for the past 3 months
6. Modified Biberoglu and Behrman (B&B) pelvic pain score of at least 5/9
7. Willing to be randomly assigned to either an active or a control group
8. Agreement to adhere to Lifestyle Considerations throughout the study duration

Exclusion Criteria

1. Smoking or drug abuse during the past six months
2. 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
3. Already following a WFPB diet
4. Pregnant or breastfeeding, or plans of pregnancy within the study period
5. Hysterectomy or ovariectomy
6. Fibroids, ovarian cysts, pelvic inflammatory disease
7. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease
8. Evidence of an eating disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total pain score	12 weeks	Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain

Trial Locations

Locations (1)

UCSD Health; 🇺🇸 La Jolla, California, United States