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Nutritional Intervention for Endometriosis

NCT05175248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-23

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Plant-based Intervention Group

Participants in the intervention group will be instructed in ways to adopt a plant-based diet, use appropriate methods of food preparation, and make meals enjoyable and appetizing. The plant-based diet primarily emphasizes whole grains, vegetables, beans and legumes, and fruits. Animal products and added oils will be proscribed and the use of ultra-processed foods, sugar, and sugar-sweetened beverages will be discouraged. Fat intake will be limited to 20-30 g/day.

Sponsors & Collaborators

  • Physicians Committee for Responsible Medicine

    lead OTHER

Principal Investigators

  • Hana Kahleova, MD, PhD · Physicians Committee for Responsible Medicine

  • Neal Barnard, MD · Physicians Committee for Responsible Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175248 on ClinicalTrials.gov