Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016, United States
NCT Number: NCT05175248
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.
This study is active but is not currently recruiting participants.
18 year–45 year
Female
Interventional
Not applicable
Washington D.C., District of Columbia, 20016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: at baseline and at 12 weeks
The EHP-30 questionnaire is the only validated quality of life questionnaire for the use in endometriosis.
Time frame: at baseline and at 12 weeks
Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).
Time frame: at baseline and at 12 weeks
Weight will be measured using a self-calibrating scale (Renpho).
Time frame: at baseline and at 12 weeks
Change in blood lipids assessed via blood tests including lipid panels.
Time frame: at baseline and at 12 weeks
Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests.
Time frame: 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.
Time frame: at baseline and at 12 weeks
Plasma levels of brain-derived neurotrophic factor (BDNF) and IL-10 will be measured through blood tests.
Physicians Committee for Responsible Medicine
Other
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
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