EndometriosisNCT04259788

An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

A study testing AHEI diet in people with Endometriosis, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Endometriosis
What is being tested?: AHEI diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 siteUnited States
Study dates: 24 May 2021to 28 Feb 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109

Other trials in United States

About this study

Conditions: Endometriosis
Being tested: AHEI diet
Keywords: Diet
Medical subject headings: Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04259788
Study group	Role	What they receive
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. Receives: Other: AHEI diet
Control	No intervention	Participants in this arm will not receive the dietary intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan
Measured: Baseline
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Measured: Baseline
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan
Measured: Baseline
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan
Measured: Week 4
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Measured: Week 4
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Measured: Week 4
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Measured: Week 8
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Measured: Week 8
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Measured: Week 8
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Inflammatory Markers
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Measured: Week 12
Protein Measurement
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Measured: Week 12
Tumor Necrosis Factor Measurement
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Measured: Week 12
Tumor Necrosis Factor Measurement #2
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Measured: Week 12

Secondary outcomes (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).
Measured: 6 months
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).
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202128 Feb 2026

First posted6 Feb 2020
Study start24 May 2021
Primary completion29 Jan 2025
Study completion28 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EndometriosisStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259788
Sponsor's protocol ID: RG1004314
Other IDs: 8772, R01NR017951
Status last verified: Jan 2026
First submitted: 9 Jan 2020
Last updated: 13 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
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Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
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Not yet recruitingPhase 2
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All Endometriosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
ClinicalTrials.gov ID: NCT04259788
Acronym / sponsor ID: RG1004314
Conditions: Endometriosis
Keywords: Diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 24 May 2021 (actual)
Primary completion: 29 Jan 2025 (actual)
Study completion: 28 Feb 2026 (actual)
First posted: 6 Feb 2020 (actual)
Results: Posted 13 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Other: AHEI dietThe 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.
Control	No intervention	–Participants in this arm will not receive the dietary intervention.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AHEI dietMain intervention is the consumption of an AHEI diet for 12 weeks.	Other	Intervention

Primary outcome

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).
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).
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.
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.
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.
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.
Inflammatory Markers
Time frame: Baseline
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan
Protein Measurement
Time frame: Baseline
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
Time frame: Baseline
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan
Tumor Necrosis Factor Measurement #2
Time frame: Baseline
Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan
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).
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).
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.
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.
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.
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.
Inflammatory Markers
Time frame: Week 4
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan
Protein Measurement
Time frame: Week 4
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
Time frame: Week 4
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
Time frame: Week 4
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
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).
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).
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.
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.
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.
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.
Inflammatory Markers
Time frame: Week 8
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Protein Measurement
Time frame: Week 8
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Tumor Necrosis Factor Measurement
Time frame: Week 8
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
Time frame: Week 8
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
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).
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).
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.
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.
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.
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.
Inflammatory Markers
Time frame: Week 12
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Protein Measurement
Time frame: Week 12
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Tumor Necrosis Factor Measurement
Time frame: Week 12
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
Time frame: Week 12
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan

4 secondary outcomes

Pain Measurement - Acyclic Pelvic Pain
Time frame: 6 months
Pain Measurement - Acyclic Pelvic Pain
Time frame: 12 months
Quality of Life EHP-30
Time frame: 6 months
Quality of Life SF-12 PC
Time frame: 12 months

Results and safety

Results posted to the registry on 13 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	51	36
Control	58	43

Primary outcome: Pain Measurement - Acyclic Pain

Time frame: Baseline to 12 weeks. Mean (95% Confidence Interval). Unit: VAS pain score

Measure	Intervention n = 48	Control n = 58
Baseline	7.1 (3.0)	7.0 (2.6)
12-weeks	4.7 (3.8 to 5.6)	6.7 (5.9 to 7.5)

Intervention vs Control: p = 0.02, linear mixed model

Primary outcome: Pain Measurement - Pain Catastrophizing

Time frame: Baseline. Mean (95% Confidence Interval). Unit: Pain catastrophizing score

Measure	Intervention n = 48	Control n = 58
Value	24.3 (20.7)	25.5 (22.2)

Primary outcome: Pain Measurement - Pills

Time frame: Baseline. Mean (95% Confidence Interval). Unit: Pain pills per week

Measure	Intervention n = 48	Control n = 58
Value	16.4 (11.5 to 21.2)	17.4 (13.0 to 21.8)

Primary outcome: Quality of Life EHP-30

Time frame: Baseline to 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Intervention n = 48	Control n = 58
Baseline	58.2 (53.8 to 62.7)	61.8 (57.8 to 65.9)
12 weeks	36.7 (30.1 to 43.2)	51.5 (45.6 to 57.4)

Intervention vs Control: p <0.0001, Linear mixed models

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 0	0 of 0	0
Control	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Participants could not be blinded to intervention arm

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Harris principal investigator

Fred Hutchinson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AHEI diet in people with Endometriosis, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Measurement - Acyclic Pain (time frame: Baseline to 12 weeks). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.