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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.
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 direct health care costs, with two-thirds attributed to loss of productivity.
Diet may play important roles in endometriosis through its effect on circulating estrogen concentrations and inflammatory processes. Reduced fat intake and increased fiber intake have been shown to reduce estrogen levels, a key determinant of endometriosis activity. Some evidence suggests a pathogenic role for the gut microbiome, which influences the mucosal immune system and pelvic inflammation. The microbiome is responsive to short term dietary intervention, although long term changes have not been well characterized.
Therefore, the investigators propose a novel intervention strategy using a plant-based diet to improve pain, inflammation, and quality of life.
The morbidity caused by endometriosis is substantial in terms of pain, reduced quality of life, lost productivity, and effects on relationships. Current medical therapies are limited in efficacy and have major side effects. Typical palliative surgery does not cure endometriosis. Better understanding of diet's ability to influence the disease process has the potential to improve quality of life and daily functioning without the cost and side effects of current therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based Intervention Group | Experimental | Intervention group participants will adopt a low-fat, plant-based diet for 12 weeks. Participants will be provided with a commercially available supplement containing 100 micrograms of vitamin B12 and asked to take it daily during the study. Alcoholic beverages will be limited to 1 per day. Participants will be asked to keep their physical activity level constant. |
|
| Control Group | No Intervention | Control group participants will be asked to maintain their usual diet for the duration of the 12-week study period. Participants will be provided with a commercially available supplement containing 100 micrograms of vitamin B12 and asked to take it daily during the study. Alcoholic beverages will be limited to 1 per day. Participants will be asked to keep their physical activity level constant. At the conclusion of the 12 weeks, control group participants will be offered instruction in the plant-based diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight: change from baseline | Weight will be measured using a self-calibrating scale (Renpho). | at baseline and at 12 weeks |
| Blood lipids: change from baseline | Change in blood lipids assessed via blood tests including lipid panels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Macy Sutton, MS | Contact | 202-527-7385 | msutton@pcrm.org | |
| Tatiana Znayenko-Miller, DrPH | Contact | 202-527-7317 | tznayenkomiller@pcrm.org |
| Name | Affiliation | Role |
|---|---|---|
| Hana Kahleova, MD, PhD | Physicians Committee for Responsible Medicine | Principal Investigator |
| Neal Barnard, MD | Physicians Committee for Responsible Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15980014 | Background | Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E; ESHRE Special Interest Group for Endometriosis and Endometrium Guideline Development Group. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698-704. doi: 10.1093/humrep/dei135. Epub 2005 Jun 24. | |
| 22562031 |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| at baseline and at 12 weeks |
| 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 |
| 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 |
| 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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| D000091662 | Genital Diseases |