Nutritional Intervention for Endometriosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Behavioral: Plant-based Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based Intervention Group<br>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. | Behavioral: Plant-based Intervention Group<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, plant-based, vegan, low-fat, diet, nutrition