An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Fred Hutchinson Cancer Center (FHCC)

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Other: AHEI diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04259788

RG1004314

R01NR017951 (U.S. NIH Grant/Contract)

8772

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: AHEI diet

Control

No Intervention group

Description:

Participants in this arm will not receive the dietary intervention.