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Completed

NCT Number: NCT04259788

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AHEI diet

Other

Main intervention is the consumption of an AHEI diet for 12 weeks.

Primary outcomes

  1. Pain Measurement - Acyclic Pain

    Time frame: Baseline to 12 weeks

    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).

  2. Pain Measurement - Pain Catastrophizing

    Time frame: Baseline

    Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).

  3. Pain Measurement - Pills

    Time frame: Baseline

    Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.

  4. Quality of Life EHP-30

    Time frame: Baseline to 12 weeks

    QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  5. Quality of Life SF-12 MC

    Time frame: Baseline to 12 weeks

    Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  6. Quality of Life SF-12 PC

    Time frame: Baseline

    Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  7. Inflammatory Markers

    Time frame: Baseline

    Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan

  8. Protein Measurement

    Time frame: Baseline

    Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan

  9. Tumor Necrosis Factor Measurement

    Time frame: Baseline

    Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan

  10. Tumor Necrosis Factor Measurement #2

    Time frame: Baseline

    Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan

  11. Pain Measurement - Acyclic Pain

    Time frame: Week 4

    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).

  12. Pain Measurement - Pain Catastrophizing

    Time frame: Week 4

    Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).

  13. Pain Measurement - Pills

    Time frame: Week 4

    Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.

  14. Quality of Life EHP-30

    Time frame: Week 4

    QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  15. Quality of Life SF-12 PC

    Time frame: Week 4

    Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  16. Quality of Life SF-12 MC

    Time frame: Week 4

    Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  17. Inflammatory Markers

    Time frame: Week 4

    Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan

  18. Protein Measurement

    Time frame: Week 4

    Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan

  19. Tumor Necrosis Factor Measurement

    Time frame: Week 4

    Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

  20. Tumor Necrosis Factor Measurement #2

    Time frame: Week 4

    Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

  21. Pain Measurement - Acyclic Pelvic Pain

    Time frame: Week 8

    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).

  22. Pain Measurement - Pain Catastrophizing Score

    Time frame: Week 8

    Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).

  23. Pain Measurement - Pills

    Time frame: Week 8

    Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.

  24. Quality of Life EHP-30

    Time frame: Week 8

    QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  25. Quality of Life SF-12 PC

    Time frame: Week 8

    Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  26. Quality of Life SF-12 MC

    Time frame: Week 8

    Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  27. Inflammatory Markers

    Time frame: Week 8

    Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan

  28. Protein Measurement

    Time frame: Week 8

    Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan

  29. Tumor Necrosis Factor Measurement

    Time frame: Week 8

    Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

  30. Tumor Necrosis Factor Measurement #2

    Time frame: Week 8

    Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

  31. Pain Measurement - Acyclic Pelvic Pain

    Time frame: Week 12

    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).

  32. Pain Measurement - Pain Catastrophizing Score

    Time frame: Week 12

    Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).

  33. Pain Measurement - Pills

    Time frame: 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.

  34. Quality of Life EHP-30

    Time frame: Week 12

    QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  35. Quality of Life SF-12 PC

    Time frame: Week 12

    Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  36. Quality of Life SF-12 MC

    Time frame: Week 12

    Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  37. Inflammatory Markers

    Time frame: Week 12

    Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan

  38. Protein Measurement

    Time frame: Week 12

    Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan

  39. Tumor Necrosis Factor Measurement

    Time frame: Week 12

    Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan

  40. Tumor Necrosis Factor Measurement #2

    Time frame: Week 12

    Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

Secondary outcomes

  1. Pain Measurement - Acyclic Pelvic Pain

    Time frame: 6 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).

  2. Pain Measurement - Acyclic Pelvic Pain

    Time frame: 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).

  3. Quality of Life EHP-30

    Time frame: 6 months

    QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

  4. Quality of Life SF-12 PC

    Time frame: 12 months

    Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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