NCT04259788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 24, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

January 9, 2020

Results QC Date

January 26, 2026

Last Update Submit

March 24, 2026

Conditions

Endometriosis

Keywords

Diet

Outcome Measures

Primary Outcomes (40)

  • Pain Measurement - Acyclic Pain

    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).

    Baseline to 12 weeks

  • Pain Measurement - Pain Catastrophizing

    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).

    Baseline

  • Pain Measurement - Pills

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

    Baseline

  • Quality of Life EHP-30

    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.

    Baseline to 12 weeks

  • Quality of Life SF-12 MC

    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.

    Baseline to 12 weeks

  • Quality of Life SF-12 PC

    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.

    Baseline

  • Inflammatory Markers

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

    Baseline

  • Protein Measurement

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

    Baseline

  • Tumor Necrosis Factor Measurement

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

    Baseline

  • Tumor Necrosis Factor Measurement #2

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

    Baseline

  • Pain Measurement - Acyclic Pain

    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).

    Week 4

  • Pain Measurement - Pain Catastrophizing

    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).

    Week 4

  • Pain Measurement - Pills

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

    Week 4

  • Quality of Life EHP-30

    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.

    Week 4

  • Quality of Life SF-12 PC

    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.

    Week 4

  • Quality of Life SF-12 MC

    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.

    Week 4

  • Inflammatory Markers

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

    Week 4

  • Protein Measurement

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

    Week 4

  • Tumor Necrosis Factor Measurement

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

    Week 4

  • Tumor Necrosis Factor Measurement #2

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

    Week 4

  • Pain Measurement - Acyclic Pelvic Pain

    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).

    Week 8

  • Pain Measurement - Pain Catastrophizing Score

    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).

    Week 8

  • Pain Measurement - Pills

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

    Week 8

  • Quality of Life EHP-30

    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.

    Week 8

  • Quality of Life SF-12 PC

    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.

    Week 8

  • Quality of Life SF-12 MC

    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.

    Week 8

  • Inflammatory Markers

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

    Week 8

  • Protein Measurement

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

    Week 8

  • Tumor Necrosis Factor Measurement

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

    Week 8

  • Tumor Necrosis Factor Measurement #2

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

    Week 8

  • Pain Measurement - Acyclic Pelvic Pain

    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).

    Week 12

  • Pain Measurement - Pain Catastrophizing Score

    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).

    Week 12

  • Pain Measurement - Pills

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

    Week 12

  • Quality of Life EHP-30

    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.

    Week 12

  • Quality of Life SF-12 PC

    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.

    Week 12

  • Quality of Life SF-12 MC

    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.

    Week 12

  • Inflammatory Markers

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

    Week 12

  • Protein Measurement

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

    Week 12

  • Tumor Necrosis Factor Measurement

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

    Week 12

  • Tumor Necrosis Factor Measurement #2

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

    Week 12

Secondary Outcomes (4)

  • Pain Measurement - Acyclic Pelvic Pain

    6 months

  • Pain Measurement - Acyclic Pelvic Pain

    12 months

  • Quality of Life EHP-30

    6 months

  • Quality of Life SF-12 PC

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: AHEI diet

Control

NO INTERVENTION

Participants in this arm will not receive the dietary intervention.

Interventions

AHEI dietOTHER

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

Intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

Participants could not be blinded to intervention arm

Results Point of Contact

Title
Holly Harris
Organization
Fred Hutchinson Cancer Center
hharris@fredhutch.org
2066672712

Study Officials

  • Holly Harris

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

February 6, 2020

Study Start

May 24, 2021

Primary Completion

January 29, 2025

Study Completion

February 28, 2026

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Participant information or blood samples could be used for future research studies or sent to other investigators for future research studies without additional consent from participants. These future research studies will be reviewed by an oversight group known as an institutional review board if required by law. The information that identifies participants will first be removed from the information or blood samples. If participants do not want their information or blood samples to be used for future research studies without their consent, interested persons should not participate in this study.

Time Frame
Data will be collected and stored indefinitely.
Access Criteria
Researchers requesting samples in the repository may apply via the completion of a material/data use agreement.

Locations

US(1)