A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

NCT07090096 | Recruiting

• 1 other identifier: 806685
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

endometriosis, pain, quality of life, inflammatory markers, diet, nutrition

Outcome Measures

Primary Outcomes (1)

• Total pain score

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

  12 weeks

Study Arms (2)

Experimental arm which will receive the intervention

EXPERIMENTAL

This group will receive the dietary intervention

Other: A whole food plant based diet

Control

NO INTERVENTION

This group with continue on their usual diet

Interventions

A whole food plant based diet OTHER

A whole food plant based (WFPB) diet

Also known as: WFPB

Experimental arm which will receive the intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Health

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjay K Agarwal, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe Delgado Ramirez

CONTACT

619-929-0828; Krupp-wellness@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study is a randomized controlled design with an active and control arms

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)