Nutritional Intervention for Endometriosis

November 2, 2023 updated by: Physicians Committee for Responsible Medicine

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Recruiting
        • Physicians Committee for Responsible Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hana Kahleova, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Plant-based Intervention Group
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.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Biberoglu and Behrman Scale: change from baseline
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.
at baseline and at 12 weeks
Endometriosis Health Profile (EHP-30): change from baseline
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.
at baseline and at 12 weeks
Inflammatory biomarkers: change from baseline
Time Frame: at baseline and at 12 weeks
Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).
at baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight: change from baseline
Time Frame: at baseline and at 12 weeks
Weight will be measured using a self-calibrating scale (Renpho).
at baseline and at 12 weeks
Blood lipids: change from baseline
Time Frame: at baseline and at 12 weeks
Change in blood lipids assessed via blood tests including lipid panels.
at baseline and at 12 weeks
Estrogen levels: change from baseline
Time Frame: at baseline and at 12 weeks
Estradiol, free estradiol, and sex hormone binding globulin (SHBG) will be measured through blood tests.
at baseline and at 12 weeks
Gut microbiome composition: change from baseline
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.
at baseline and at 12 weeks
Biomarkers of endometriosis and inflammation: change from baseline
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.
at baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physicians Committee for Responsible Medicine

Investigators

  • Principal Investigator: Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine
  • Study Director: Neal Barnard, MD, Physicians Committee for Responsible Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00059650

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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