Nutritional Intervention for Endometriosis
NCT05175248
· ctgov
active_not_recruiting
- Enrollment
- 120
- Start
- 2022-03-02
- Completion
- 2029-12-01
- Last updated
- 2026-10-20
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
-
Plant-based Intervention Group
BEHAVIORAL
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.
Eligibility 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
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine