A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

NCT ID: NCT07090096

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-10-01

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental arm which will receive the intervention

This group will receive the dietary intervention

Group Type: EXPERIMENTAL

A whole food plant based diet

Intervention Type: OTHER

A whole food plant based (WFPB) diet

Control

This group with continue on their usual diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A whole food plant based diet

A whole food plant based (WFPB) diet

Intervention Type: OTHER

Other Intervention Names

WFPB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sanjay Agarwal, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanjay K Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Health

La Jolla, California, United States

Countries

United States

Central Contacts

Tanya Shekhtman

Role: CONTACT

tshekhtman@health.ucsd.edu

858-642-1266

Facility Contacts

Fernando Martinez

Role: primary

fmartinez@health.ucsd.edu

United States ext. 8585348930

Sanjay Agarwal, MD

Role: backup

skagarwal@health.ucsd.edu

United States ext. 8585348930

Other Identifiers

806685

Identifier Type: -

Identifier Source: org_study_id