A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

University of California San Diego

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Other: A whole food plant based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07090096

806685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Experimental arm which will receive the intervention

Experimental group

Description:

This group will receive the dietary intervention

Treatment:

Other: A whole food plant based diet

Control

No Intervention group

Description:

This group with continue on their usual diet