Endometriosis
Conditions
Keywords
endometriosis, pain, quality of life, inflammatory markers, diet, nutrition
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.
Interventions
OTHERA whole food plant based diet
A whole food plant based (WFPB) diet
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study is a randomized controlled design with an active and control arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total pain score | 12 weeks | Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain |
Countries
United States
Contacts
CONTACTChloe Delgado Ramirez
PRINCIPAL_INVESTIGATORSanjay K Agarwal, MD
UCSD
Outcome results
None listed