An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
NCT ID: NCT04259788
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
109 participants
INTERVENTIONAL
2021-05-24
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention
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.
AHEI diet
Main intervention is the consumption of an AHEI diet for 12 weeks.
Control
Participants in this arm will not receive the dietary intervention.
No interventions assigned to this group
Interventions
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AHEI diet
Main intervention is the consumption of an AHEI diet for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Holly Harris
Principal Investigator
Principal Investigators
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Holly Harris
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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8772
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004314
Identifier Type: -
Identifier Source: org_study_id
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