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AHEI Diet for Endometriosis

N/A

Recruiting

Led By Holly Harris

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Aged 18-45

Must not have

Postmenopausal

Have had a hysterectomy or oophorectomy

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a healthy diet can help ease endometriosis pain and improve quality of life.

Who is the study for?

This trial is for premenopausal women aged 18-45 with laparoscopically confirmed endometriosis and significant pain (VAS score of at least 7 out of 10). Participants should have a poor diet as indicated by an AHEI-2010 score below 75. Women who are pregnant, postmenopausal, or have certain chronic illnesses affecting nutrient absorption cannot join.

What is being tested?

The study tests whether following the Alternative Healthy Eating Index (AHEI) diet can reduce pain and improve quality of life in women with endometriosis. It also looks at changes in inflammatory markers from blood samples to assess the diet's impact on inflammation.

What are the potential side effects?

Since this intervention involves dietary changes rather than medication, side effects may include initial digestive discomfort as the body adjusts to new eating habits. No severe side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am between 18 and 45 years old.

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I have had at least one menstrual period in the last 6 months.

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I have experienced significant pain, scoring 7 or more, in the last 3 months.

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I am female.

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I am between 18 and 45 years old.

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My endometriosis was confirmed through a laparoscopy.

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I have had at least one menstrual period in the last 6 months.

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I have experienced severe pain, scoring 7 or more, in the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am postmenopausal.

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I have had a hysterectomy or oophorectomy.

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I have a chronic illness like celiac, Crohn's, ulcerative colitis, or cystic fibrosis.

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I have a history of kidney stones, cancer (other than skin cancer), or diabetes.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inflammatory Markers

Pain

Protein Measurement

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 Intervention

Participants in this arm will not receive the dietary intervention.

0 / 13Eligibility criteria met