Nutritional Intervention for Endometriosis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Physicians Committee for Responsible Medicine
Study ID
NCT05175248
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 2, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Modified Biberoglu and Behrman Scale: change from baseline [ Time Frame: at baseline and at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Physicians Committee for Responsible MedicineWashington D.C.District of Columbia20016
Macy Sutton, MS
[email protected]
2025277385
Tatiana Znayenko-Miller, DrPH
[email protected]
2025277317
Hana Kahleova, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Physicians Committee for Responsible Medicine· Washington D.C., DC

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