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NCT05175248Active, not recruiting

Nutritional Intervention for Endometriosis

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
14 Dec 2021
Start date
2 Mar 2022
Primary completion date
Dec 2029
Lead sponsor
Physicians Committee for Responsible Medicine
NCT number
NCT05175248

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 2 Mar 2022 to the primary completion date, Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Smoking or drug abuse during the past six months

Other illness

  • 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
  • Unstable medical or psychiatric illness
  • 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

Other

  • Body mass index ≥ 40 kg/m2
  • Already following a plant-based diet
  • Pregnant or breastfeeding, or plans of pregnancy within the study period
  • Hysterectomy or ovariectomy
  • Lack of English fluency
  • Unable or unwilling to participate in all components of the study

Who the study is looking for

  • Women with a surgical, imaging, or clinical diagnosis of endometriosis
  • Age 18-45 years
  • Stable health condition and medications for past 3 months
  • Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9
  • Able to follow a plant-based diet for 12 weeks
  • 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

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Physicians Committee for Responsible Medicine
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.