A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A whole food plant based diet.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other A whole food plant based diet
A whole food plant based (WFPB) diet
Primary outcome measures
- Total pain score [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UCSD Health — La Jolla
Identifiers
NCT: NCT07090096 · 806685