N/A
Completed N=109
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Source: ClinicalTrials.gov NCT04259788 ↗Enrolled (actual)
109
Serious AEs
—
Results posted
Apr 2026
Primary outcomePrimary: Pain Measurement - Acyclic Pain — 7.1; 7.0; 4.7; 6.7 VAS pain score — p=0.02
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.
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 Pelvic Pain |
4; 5 | — |
| PRIMARY Pain Measurement - Pain Catastrophizing Score |
13.6; 21.3 | — |
| 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 | — |
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
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. Informational only — not medical advice.