Nutritional Intervention for Endometriosis

NCT05175248 | Recruiting

• 1 other identifier: Pro00059650
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

endometriosis; plant-based; vegan; low-fat; diet; nutrition

Outcome Measures

Primary Outcomes (3)

• 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.

  at baseline and at 12 weeks

• 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.

  at baseline and at 12 weeks

• Inflammatory biomarkers: change from baseline

  Blood tests for biomarkers of inflammation (hsCRP, TNF-alpha, IL-1 beta and IL-6).

  at baseline and at 12 weeks

Secondary Outcomes (5)

• Body weight: change from baseline

  at baseline and at 12 weeks

• Blood lipids: change from baseline

  at baseline and at 12 weeks

• Estrogen levels: change from baseline

  at baseline and at 12 weeks

• Gut microbiome composition: change from baseline

  at baseline and at 12 weeks

• Biomarkers of endometriosis and inflammation: change from baseline

  at baseline and at 12 weeks

Study Arms (2)

Plant-based Intervention Group

EXPERIMENTAL

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

Control Group

NO 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.

Interventions

Plant-based Intervention Group BEHAVIORAL

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.

Plant-based Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Able to follow a plant-based diet for 12 weeks
• 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

You may not qualify if:

• 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
• Already following a plant-based diet
• Pregnant or breastfeeding, or plans of pregnancy within the study period
• Hysterectomy or ovariectomy
• Fibroids, ovarian cysts, pelvic inflammatory disease
• Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease
• Lack of English fluency
• Unable or unwilling to participate in all components of the study
• Evidence of an eating disorder

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Related Publications (25)

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  BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hana Kahleova, MD, PhD

  Physicians Committee for Responsible Medicine

  PRINCIPAL INVESTIGATOR

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  STUDY DIRECTOR

Central Study Contacts

Macy Sutton, MS

CONTACT

202-527-7385; msutton@pcrm.org

Tatiana Znayenko-Miller, DrPH

CONTACT

202-527-7317; tznayenkomiller@pcrm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: March 2, 2022
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)