Endometriosis Clinical Trial
Official title:
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
NCT number | NCT05175248 |
Other study ID # | Pro00059650 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2022 |
Est. completion date | August 2025 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Physicians Committee for Responsible Medicine | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Physicians Committee for Responsible Medicine |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Biberoglu and Behrman Scale: change from baseline | Endometriosis-specific pain scale will be used. For inclusion in study, participants require a score of at least 5/9. | at baseline and at 12 weeks | |
Primary | Endometriosis Health Profile (EHP-30): change from baseline | The EHP-30 questionnaire is the only validated quality of life questionnaire for the use in endometriosis. | at baseline and at 12 weeks | |
Primary | Inflammatory biomarkers: change from baseline | Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6). | at baseline and at 12 weeks | |
Secondary | Body weight: change from baseline | Weight will be measured using a self-calibrating scale (Renpho). | at baseline and at 12 weeks | |
Secondary | Blood lipids: change from baseline | Change in blood lipids assessed via blood tests including lipid panels. | at baseline and at 12 weeks | |
Secondary | Estrogen levels: change from baseline | Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests. | at baseline and at 12 weeks | |
Secondary | Gut microbiome composition: change from baseline | Participants will collect stool samples for microbiome analysis. Sample collection will be carried out using home collection procedures with samples returned through local post. The participants will apply a small smear to the tips of a swab from used toilet paper. The swab will, in turn, be used to transfer the smear to a fecal occult blood test (FOBT) card that will be returned by mail to a laboratory for analysis. | at baseline and at 12 weeks | |
Secondary | Biomarkers of endometriosis and inflammation: change from baseline | Plasma levels of brain-derived neurotrophic factor (BDNF) and IL-10 will be measured through blood tests. | at baseline and at 12 weeks |
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