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Plant-Based Diet for Endometriosis

N/A

Recruiting

Led By Hana Kahleova, MD, PhD

Research Sponsored by Physicians Committee for Responsible Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with a surgical, imaging, or clinical diagnosis of endometriosis

Age 18-45 years

Must not have

Unstable medical or psychiatric illness

Hysterectomy or ovariectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a low-fat plant-based diet to no change in diet in women with endometriosis.

Who is the study for?

This trial is for women aged 18-45 with endometriosis confirmed by surgery, imaging, or clinical diagnosis. Participants should be in stable health and not have had any changes to their medications in the past three months. They must have a certain level of pelvic pain and be willing to potentially switch to a plant-based diet for 12 weeks.

What is being tested?

The study compares the effects of a low-fat plant-based diet versus usual diets over 12 weeks on women with endometriosis. It measures changes in pain, quality of life, inflammatory markers, body weight, blood lipids, gut microbiome composition, and hormonal levels without altering exercise habits.

What are the potential side effects?

While specific side effects are not listed for this nutritional intervention trial, participants may experience digestive adjustments due to dietary changes such as bloating or gas when starting a plant-based diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with endometriosis.

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I am between 18 and 45 years old.

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My health and medications have been stable for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable medical or mental health conditions.

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I have had a hysterectomy or ovariectomy.

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I have a condition like Cushing's, Hashimoto's, Graves', type 1 diabetes, or Addison's.

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I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endometriosis Health Profile (EHP-30): change from baseline

Inflammatory biomarkers: change from baseline

Modified Biberoglu and Behrman Scale: change from baseline

Secondary study objectives

Biomarkers of endometriosis and inflammation: change from baseline

Blood lipids: change from baseline

Body weight: change from baseline

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Plant-based Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupActive Control1 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.

0 / 7Eligibility criteria met