A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

NCT05175248 NA RECRUITING

In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.

Details

Lead sponsor	Physicians Committee for Responsible Medicine
Phase	NA
Status	RECRUITING
Enrolment	120
Start date	2022-03-02
Completion	2029-12

Conditions

• Endometriosis

Interventions

• Plant-based Intervention Group

Primary outcomes

• Modified Biberoglu and Behrman Scale: change from baseline — at baseline and at 12 weeks
  Endometriosis-specific pain scale will be used. For inclusion in study, participants require a score of at least 5/9.
• Endometriosis Health Profile (EHP-30): change from baseline — at baseline and at 12 weeks
  The EHP-30 questionnaire is the only validated quality of life questionnaire for the use in endometriosis.
• Inflammatory biomarkers: change from baseline — at baseline and at 12 weeks
  Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).

Countries

United States