NCT05175248 · Physicians Committee for Responsible Medicine
Nutritional Intervention for Endometriosis
What this study is about
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.
View original scientific 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.
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.
Primary outcome measures
Modified Biberoglu and Behrman Scale: change from baseline
Time frame: 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
Time frame: 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
Time frame: at baseline and at 12 weeks
Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Body mass index ≥ 40 kg/m2
- 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
- Unstable medical or psychiatric illness
- Already following a plant-based 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
- Lack of English fluency
- Unable or unwilling to participate in all components of the study
- Evidence of an eating disorder
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations