Nutritional Intervention for Endometriosis
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPhysicians Committee for Responsible Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Plant-based Intervention Group
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Plant-based Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
at baseline and at 12 weeks2
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.
Time frame
at baseline and at 12 weeks3
Inflammatory biomarkers: change from baseline
Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).
Time frame
at baseline and at 12 weeksSecondary outcomes
1
Body weight: change from baseline
Weight will be measured using a self-calibrating scale (Renpho).
Time frame
at baseline and at 12 weeks2
Blood lipids: change from baseline
Change in blood lipids assessed via blood tests including lipid panels.
Time frame
at baseline and at 12 weeks3
Estrogen levels: change from baseline
Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests.
Time frame
at baseline and at 12 weeks4
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.
Time frame
at baseline and at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov