An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Other: AHEI diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Main intervention is the consumption of an AHEI diet for 12 weeks.<br>|
| No Intervention: Control<br>Participants in this arm will not receive the dietary intervention. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet