Plant-based diet intervention for women with endometriosis
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
This study is testing if a low-fat plant-based diet can help women with endometriosis feel better and improve their overall health compared to their usual diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Physicians Committee for Responsible Medicine Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT05175248 on ClinicalTrials.gov |
What this trial studies
This study involves a 12-week intervention where women diagnosed with endometriosis will be randomly assigned to either a low-fat plant-based diet or their usual diet. The primary outcomes measured will include changes in pain levels, quality of life, and inflammatory biomarkers. Secondary outcomes will assess body weight, blood lipids, gut microbiome composition, and hormonal changes. The goal is to evaluate the impact of dietary changes on the symptoms and overall health of women suffering from this chronic condition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a confirmed diagnosis of endometriosis who can adhere to a plant-based diet for the duration of the study.
Not a fit: Patients with a body mass index of 40 kg/m2 or higher, or those already following a plant-based diet, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive dietary approach to alleviate pain and improve quality of life for women with endometriosis.
How similar studies have performed: While dietary interventions for endometriosis are not extensively studied, some evidence suggests that dietary changes can positively influence symptoms, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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
Where this trial is running
Washington D.C., District of Columbia
- Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Hana Kahleova, MD, PhD — Physicians Committee for Responsible Medicine
- Study coordinator: Macy Sutton, MS
- Email: msutton@pcrm.org
- Phone: 202-527-7385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.