A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
Physicians Committee for Responsible Medicine
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.
Description
Endometriosis is a chronic, painful condition that affects 5-10% of reproductive aged women. It is characterized by the presence of endometrial cells outside the uterus, causing pain and infertility. Current therapies to temporarily control symptoms include surgery and medical options with significant side effects. Women with endometriosis may have several surgeries by their mid-20s. The medical costs associated with endometriosis in the US alone are about $3.6 billion annually, and the total annual health care cost associated with endometriosis in 2002 was $22 billion, one-third of which is d…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- BehavioralPlant-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.
Location
- Physicians Committee for Responsible MedicineWashington D.C., District of Columbia