CompletedNot Applicable

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

United States109 participantsStarted 2021-05-24

Plain-language summary

The investigators are conducting this study to examine if a healthy diet based on the Alternative Healthy Eating Index (AHEI) influences pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who are currently experiencing pain symptoms.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Aged 18-45 * Laparoscopically-confirmed endometriosis * Premenopausal (at least one period in the past 6 months) * VAS pain score of at least 7 out of 10 in the previous 3 months * Score below 75 on the AHEI-2010 Exclusion Criteria: * Postmenopausal * Pregnant * Have had a hysterectomy or oophorectomy * Have chronic illnesses that are known to affect gastrointestinal absorption of nutrients (celiac disease, Crohn's disease, ulcerative colitis, or cystic fibrosis) * A history of kidney stones, cancer (except basal cell carcinoma), or diabetes

What they're measuring

Pain Measurement - Acyclic Pain

Timeframe: Baseline to 12 weeks

Pain Measurement - Pain Catastrophizing

Timeframe: Baseline

Pain Measurement - Pills

Timeframe: Baseline

Quality of Life EHP-30

Timeframe: Baseline to 12 weeks

Quality of Life SF-12 MC

Timeframe: Baseline to 12 weeks

Quality of Life SF-12 PC

Timeframe: Baseline

Inflammatory Markers

Timeframe: Baseline

Protein Measurement

Timeframe: Baseline

Tumor Necrosis Factor Measurement

Timeframe: Baseline

Trial details

NCT IDNCT04259788

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-29

Results submitted2026-01-26

View on ClinicalTrials.gov More Endometriosis trials