An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04259788
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 24, 2021
Status verified
Jan 2026
Primary completion
Jan 29, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
109 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: Control
    Participants in this arm will not receive the dietary intervention.

Primary Outcome Measure

Pain Measurement - Acyclic Pain [ Time Frame: Baseline to 12 weeks ]

Locations (1)

FacilityCityStateZIP
Fred Hutchinson Cancer Research CenterSeattleWashington98109

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