Nutritional Intervention for Endometriosis

Not Applicable

Recruiting

• Conditions: Endometriosis
• Interventions: Behavioral: Plant-based Intervention Group

• Registration Number: NCT05175248
• Lead Sponsor: Physicians Committee for Responsible Medicine

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Study Start: 2022-03-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant-based Intervention Group	Plant-based Intervention Group	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.

Primary Outcome Measures

Name	Time	Method
Endometriosis Health Profile (EHP-30): change from baseline	at baseline and at 12 weeks	The EHP-30 questionnaire is the only validated quality of life questionnaire for the use in endometriosis.
Modified Biberoglu and Behrman Scale: change from baseline	at baseline and at 12 weeks	Endometriosis-specific pain scale will be used. For inclusion in study, participants require a score of at least 5/9.
Inflammatory biomarkers: change from baseline	at baseline and at 12 weeks	Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).

Secondary Outcome Measures

Name	Time	Method
Body weight: change from baseline	at baseline and at 12 weeks	Weight will be measured using a self-calibrating scale (Renpho).
Blood lipids: change from baseline	at baseline and at 12 weeks	Change in blood lipids assessed via blood tests including lipid panels.
Estrogen levels: change from baseline	at baseline and at 12 weeks	Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests.
Biomarkers of endometriosis and inflammation: change from baseline	at baseline and at 12 weeks	Plasma levels of brain-derived neurotrophic factor (BDNF) and IL-10 will be measured through blood tests.
Gut microbiome composition: change from baseline	at baseline and at 12 weeks	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.

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, DC, District of Columbia, United States