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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Inflammatory biomarkers: change from baseline

Modified Biberoglu and Behrman Scale: change from baseline

Secondary outcome measures

Biomarkers of endometriosis and inflammation: change from baseline

Blood lipids: change from baseline

Body weight: change from baseline

+2 more

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 / 3Eligibility criteria met

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Who is running the clinical trial?

Physicians Committee for Responsible MedicineLead Sponsor

29 Previous Clinical Trials

2,505 Total Patients Enrolled

Hana Kahleova, MD, PhDPrincipal InvestigatorPhysicians Committee for Responsible Medicine

3 Previous Clinical Trials

115 Total Patients Enrolled

Neal Barnard, MDStudy DirectorPhysicians Committee for Responsible Medicine

9 Previous Clinical Trials

1,173 Total Patients Enrolled

Media Library

Plant-based Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05175248 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for participation in this research experiment?

"To be eligible for this investigation, subjects should have endometrioma and must fall between 18-45 years of age. Presently, researchers are seeking to recruit approximately 120 individuals."

Answered by AI

What results are desired from this research endeavor?

"The primary evaluation metric for this medical study is the Endometriosis Health Profile (EHP-30) at baseline and after a 12 week period. Secondary objectives include measuring biomarkers of endometriosis, inflammation, estrogen levels and body weight with blood tests or scales."

Answered by AI

Is there still opportunity for volunteers to join this research endeavor?

"Patient recruitment is open for this research, which was first made available on March 2nd 2022 and has seen recent revisions on September 27th."

Answered by AI

Does this experiment allow individuals aged 45 and older to participate?

"The age range for eligibility in this trial is 18-45, as specified by the inclusion criteria."

Answered by AI

How many individuals have registered for this research endeavor?

"Affirmative. According to clinicaltrials.gov, recruitment is ongoing for this research study that was first made available on March 2nd 2022 and last updated September 27th 2022. In total 120 individuals must be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?

Maryland

California

Washington

Other

How old are they?

18 - 65

What site did they apply to?

Physicians Committee for Responsible Medicine

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I’ve tried plant based diets in the past and have seen physical changes, pain level changes and mental health changes.

PatientReceived 2+ prior treatments

I was diagnosed after my RE didn’t know why I was unable to get pregnant despite “normal” fertility screenings and failed IVF / IUI, and they suggested I be screened. I was relieved to get the diagnosis because it felt like we were actually addressing a problem, as opposed to just throwing more medications at it. But it’s also frustrating because my doctors should have suggested this at least 10 years ago when I came in with severe pain with periods, and again 2.5 years ago when I was having difficulty conceiving.

PatientReceived 1 prior treatment