An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: AHEI diet

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Blythe; Phone Number: 2066676900; Email: nblythe@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Research Center
      • Contact: Nancy A Blythe, BA; Phone Number: 206-667-6900; Email: nblythe@fhcrc.org
      • Principal Investigator: Holly R Harris, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: AHEI diet; Main intervention is the consumption of an AHEI diet for 12 weeks.
No Intervention: Control; Participants in this arm will not receive the dietary intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Measurement	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).	Baseline
Pain Measurement	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).	Baseline
Pain Measurement	Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.	Baseline
Quality of Life Questionnaire	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.	Baseline
Quality of Life Survey	Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.	Baseline
Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.	Baseline
Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Baseline
Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Baseline
Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Baseline
Pain Measurement	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).	Week 4
Pain Measurement	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).	Week 4
Pain Measurement	Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.	Week 4
Quality of Life Questionnaire	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.	Week 4
Quality of Life Survey	Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.	Week 4
Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.	Week 4
Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 4
Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 4
Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 4
Pain Measurement	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).	Week 8
Pain Measurement	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).	Week 8
Pain Measurement	Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.	Week 8
Quality of Life Questionnaire	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.	Week 8
Quality of Life Survey	Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.	Week 8
Inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.	Week 8
Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 8
Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 8
Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 8
Pain Measurement	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).	Week 12
Pain Measurement	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).	Week 12
Pain Measurement	Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.	Week 12
Quality of Life Questionnaire	Physical and mental QOL components will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.	Week 12
Quality of Life Survey	Physical and mental QOL components will be measured with the Short Form-12 survey. There are two components, a physical component summary (PCS) and a mental health component summary (MCS). Both have a range of 0 to 100, higher scores represent better health.	Week 12
inflammatory Markers	Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.	Week 12
Protein Measurement	Measurement of circulating levels of high sensitivity-C-reactive protein.	Week 12
Tumor Necrosis Factor Measurement	Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1.	Week 12
Tumor Necrosis Factor Measurement #2	Measurement of circulating levels of soluble TNF alpha-receptor 2.	Week 12

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Holly Harris, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diet
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: RG1004314; 8772 (Other Identifier: FHCRC IRB Number); R01NR017951 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be collected and stored indefinitely.
• IPD Sharing Access Criteria: Researchers requesting samples in the repository may apply via the completion of a material/data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No