A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: Female

Minimum Age: 18

Maximum Age: 45

Healthy Volunteers: f

View:

• 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

Locations

United States

Washington, D.c.

Physicians Committee for Responsible Medicine

RECRUITING

Washington D.c.

Contact Information

Primary

Macy Sutton, MS

msutton@pcrm.org

202-527-7385

Backup

Tatiana Znayenko-Miller, MS

tznayenkomiller@pcrm.org

202-527-7317

Time Frame

Start Date: 2022-03-02

Estimated Completion Date: 2025-11

Participants

Target number of participants: 120

Treatments

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.

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.

Authors

Hana Kahleova

Related Therapeutic Areas

Endometriosis

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