Nutritional Intervention for Endometriosis
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
Physicians Committee for Responsible Medicine
120 participants
Mar 2, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria12
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05175248