An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Not Applicable

Active, not recruiting

• Conditions: Endometriosis
• Interventions: Other: AHEI diet

• Registration Number: NCT04259788
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2021-05-24
• Primary Completion: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AHEI diet	The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period and discontinue any vitamin or supplement intake during this time. During the first 4 weeks 2 meals and 1 snack/day will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.

Primary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire	Week 12	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Pain Measurement	Week 12	Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Quality of Life Survey	Week 12	Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.
Tumor Necrosis Factor Measurement	Week 12	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.
Inflammatory Markers	Week 8	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Protein Measurement	Week 12	Measurement of circulating levels of high sensitivity-C-reactive protein.
Tumor Necrosis Factor Measurement #2	Week 12	Measurement of circulating levels of soluble TNF alpha-receptor 2.
inflammatory Markers	Week 12	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.

Secondary Outcome Measures

Name	Time	Method
Pain Measurement	12 months	Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Qualify of Life Questionnaire	6 months	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Quality of Life Questionnaire	12 months	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States