A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
Recruiting · NCT07090096 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
A whole food plant based diet
What this trial is 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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- UCSD Health - La Jolla, California, United States