N/A N=109 Randomized Single-blind Treatment

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Endometriosis

Bottom Line

View on ClinicalTrials.gov: NCT04259788 ↗

Enrolled (actual)

109

Serious AEs

—

Results posted

Apr 2026

Primary outcome: Primary: Pain Measurement - Acyclic Pain — 7.1; 7.0; 4.7; 6.7 VAS pain score — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AHEI diet (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Jan 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Measurement - Acyclic Pain	6.3; 6.9	—
PRIMARY Pain Measurement - Pain Catastrophizing	16.7; 23.0	—
PRIMARY Pain Measurement - Pills	12.2; 12.4	—
PRIMARY Quality of Life EHP-30	40; 48	—
PRIMARY Quality of Life SF-12 MC	42.3; 38.8	—
PRIMARY Quality of Life SF-12 PC	31; 44	—
PRIMARY Inflammatory Markers	236.0; 228.6	—
PRIMARY Protein Measurement	33287; 34894	—
PRIMARY Tumor Necrosis Factor Measurement	7136.3; 7503.6	—
PRIMARY Tumor Necrosis Factor Measurement #2	1531.6; 1677	—
PRIMARY Pain Measurement - Acyclic Pain	6.3; 6.9	—
PRIMARY Pain Measurement - Pain Catastrophizing	16.7; 23.0	—
PRIMARY Pain Measurement - Pills	12.2; 12.4	—
PRIMARY Quality of Life EHP-30	40; 48	—
PRIMARY Quality of Life SF-12 PC	31; 44	—
PRIMARY Quality of Life SF-12 MC	42.3; 38.8	—
PRIMARY Inflammatory Markers	236.0; 228.6	—
PRIMARY Protein Measurement	33287; 34894	—
PRIMARY Tumor Necrosis Factor Measurement	7136.3; 7503.6	—
PRIMARY Tumor Necrosis Factor Measurement #2	1531.6; 1677	—
PRIMARY Pain Measurement - Acyclic Pelvic Pain	4; 5	—
PRIMARY Pain Measurement - Pain Catastrophizing Score	13.6; 21.3	—
PRIMARY Pain Measurement - Pills	12.2; 12.4	—
PRIMARY Quality of Life EHP-30	40; 48	—
PRIMARY Quality of Life SF-12 PC	31; 44	—
PRIMARY Quality of Life SF-12 MC	42.3; 38.8	—
PRIMARY Inflammatory Markers	236.0; 228.6	—
PRIMARY Protein Measurement	33287; 34894	—
PRIMARY Tumor Necrosis Factor Measurement	7136.3; 7503.6	—
PRIMARY Tumor Necrosis Factor Measurement #2	1531.6; 1677	—
PRIMARY Pain Measurement - Acyclic Pelvic Pain	4; 5	—
PRIMARY Pain Measurement - Pain Catastrophizing Score	13.6; 21.3	—
PRIMARY Pain Measurement - Pills	12.2; 12.4	—
PRIMARY Quality of Life EHP-30	40; 48	—
PRIMARY Quality of Life SF-12 PC	31; 44	—
PRIMARY Quality of Life SF-12 MC	42.3; 38.8	—
PRIMARY Inflammatory Markers	236.0; 228.6	—
PRIMARY Protein Measurement	33287; 34894	—
PRIMARY Tumor Necrosis Factor Measurement	7136.3; 7503.6	—
PRIMARY Tumor Necrosis Factor Measurement #2	1531.6; 1677	—
SECONDARY Pain Measurement - Acyclic Pelvic Pain	4; 5	—
SECONDARY Pain Measurement - Acyclic Pelvic Pain	4; 5	—
SECONDARY Quality of Life EHP-30	40; 48	—
SECONDARY Quality of Life SF-12 PC	31; 44	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04259788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.