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NCT Number: NCT07090096

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Health

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Fernando Martinez

CONTACT

[email protected]

United States ext. 8585348930

Sanjay Agarwal, MD

CONTACT

[email protected]

United States ext. 8585348930

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • Evidence of an eating disorder

Treatment and study plan

A whole food plant based diet

Other

A whole food plant based (WFPB) diet

Other names: WFPB

Primary outcomes

  1. Total pain score

    Time frame: 12 weeks

    Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain

Study contacts

Contact information is provided by the study sponsor or research team.

Chloe Delgado Ramirez

CONTACT

[email protected]

619-929-0828

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 29, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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