A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Total pain score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
This group with continue on their usual diet
Experimental arm which will receive the intervention
This group will receive the dietary intervention
Intervention: A whole food plant based diet (Other)
Outcomes
Primary Outcomes
Total pain score
Time Frame: 12 weeks
Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Sanjay Agarwal, MD
Clinical Professor
University of California, San Diego