Nutritional Intervention for Endometriosis

Description

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.

Conditions

Endometriosis

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Nutritional Intervention for Endometriosis

Condition
Endometriosis
Intervention / Treatment

-

Contacts and Locations

Washington, DC

Physicians Committee for Responsible Medicine, Washington, DC, District of Columbia, United States, 20016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Women with a surgical, imaging, or clinical diagnosis of endometriosis
  • 2. Age 18-45 years
  • 3. Stable health condition and medications for past 3 months
  • 4. Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9
  • 5. Able to follow a plant-based diet for 12 weeks
  • 6. Willing to be randomly assigned to either a plant-based group or a control group that will not make any dietary changes for 12 weeks
  • 1. Body mass index ≥ 40 kg/m2
  • 2. Smoking or drug abuse during the past six months
  • 3. 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
  • 4. Unstable medical or psychiatric illness
  • 5. Already following a plant-based diet
  • 6. Pregnant or breastfeeding, or plans of pregnancy within the study period
  • 7. Hysterectomy or ovariectomy
  • 8. Fibroids, ovarian cysts, pelvic inflammatory disease
  • 9. Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease
  • 10. Lack of English fluency
  • 11. Unable or unwilling to participate in all components of the study
  • 12. Evidence of an eating disorder

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Physicians Committee for Responsible Medicine,

Hana Kahleova, MD, PhD, PRINCIPAL_INVESTIGATOR, Physicians Committee for Responsible Medicine

Neal Barnard, MD, STUDY_DIRECTOR, Physicians Committee for Responsible Medicine

Study Record Dates

2025-11