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| ID | Type | Description | Link |
|---|---|---|---|
| 8772 | Other Identifier | FHCRC IRB Number | |
| R01NR017951 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | Participants in this arm will not receive the dietary intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHEI diet | Other | Main intervention is the consumption of an AHEI diet for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measurement - Acyclic Pain | 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 to 12 weeks |
| Pain Measurement - Pain Catastrophizing | 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 - Pills | 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 EHP-30 | QOL 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 to 12 weeks |
| Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Baseline to 12 weeks |
| Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Baseline |
| Inflammatory Markers |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measurement - Acyclic Pelvic Pain | 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). | 6 months |
| Pain Measurement - Acyclic Pelvic Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Harris | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
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.
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Data will be collected and stored indefinitely.
Researchers requesting samples in the repository may apply via the completion of a material/data use agreement.
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Tailored, adaptive social media advertisements were developed and implemented by BuildClinical, LLC, and the Fred Hutch Marketing and Communications Social Media Team. Flyers/brochures were distributed at local and national organizations. Participants were also recruited from Kaiser Permanente Washington (KPW). Potentially eligible KPW members aged 18-45 years were identified using Kaiser Permanente Washington Health Research Institute (KPWHRI) electronic administrative and clinical data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. During the first 4 weeks meals and snacks 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. |
| FG001 | Control | Participants in this arm will not receive the dietary intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 participants in the intervention arm were deemed to be fraudulent so were not included in analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants in this arm will not receive the dietary intervention. |
| BG001 | 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. During the first 4 weeks meals and snacks 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Measurement - Acyclic Pain | 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). | Posted | Mean | 95% Confidence Interval | VAS pain score | Baseline to 12 weeks |
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Participants could not be blinded to intervention arm
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Harris | Fred Hutchinson Cancer Center | 2066672712 | hharris@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2024 | Jan 26, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2024 | Jan 26, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan |
| Baseline |
| Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan | Baseline |
| Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan | Baseline |
| Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan | Baseline |
| Pain Measurement - Acyclic Pain | 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 Catastrophizing | 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 - Pills | 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 EHP-30 | QOL 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 SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 4 |
| Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 4 |
| Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan | Week 4 |
| Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan | Week 4 |
| Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Week 4 |
| Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Week 4 |
| Pain Measurement - Acyclic Pelvic Pain | 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 Catastrophizing Score | 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 - Pills | 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 EHP-30 | QOL 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 SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 8 |
| Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 8 |
| Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan | Week 8 |
| Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan | Week 8 |
| Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Week 8 |
| Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Week 8 |
| Pain Measurement - Acyclic Pelvic Pain | 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 Catastrophizing Score | 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 - Pills | 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 EHP-30 | QOL 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 SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 12 |
| Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Week 12 |
| Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan | Week 12 |
| Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan | Week 12 |
| Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Week 12 |
| Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Week 12 |
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). |
| 12 months |
| Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | 6 months |
| Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline acyclic pelvic pain | 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). | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Pain Measurement - Pain Catastrophizing | 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). | Posted | Mean | 95% Confidence Interval | Pain catastrophizing score | Baseline |
|
|
|
| Primary | Pain Measurement - Pills | Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week. | Posted | Mean | 95% Confidence Interval | Pain pills per week | Baseline |
|
|
|
| Primary | Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Primary | Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 12 weeks |
|
|
|
|
| Primary | Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline |
|
|
|
| Primary | Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Baseline |
|
|
|
| Primary | Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Baseline |
|
|
|
| Primary | Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Baseline |
|
|
|
| Primary | Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Baseline |
|
|
|
| Primary | Pain Measurement - Acyclic Pain | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
| Primary | Pain Measurement - Pain Catastrophizing | 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). | Posted | Mean | 95% Confidence Interval | pain catastrophizing score | Week 4 |
|
|
|
| Primary | Pain Measurement - Pills | Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week. | Posted | Mean | 95% Confidence Interval | Pain pills per week | Week 4 |
|
|
|
| Primary | Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
| Primary | Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
| Primary | Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 4 |
|
|
|
| Primary | Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 4 |
|
|
|
| Primary | Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 4 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 4 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 4 |
|
|
|
| Primary | Pain Measurement - Acyclic Pelvic Pain | 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). | Posted | Mean | 95% Confidence Interval | VAS pain score | Week 8 |
|
|
|
| Primary | Pain Measurement - Pain Catastrophizing Score | 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). | Posted | Mean | 95% Confidence Interval | pain catastrophizing score | Week 8 |
|
|
|
| Primary | Pain Measurement - Pills | Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week. | Posted | Mean | 95% Confidence Interval | Pain pills per week | Week 8 |
|
|
|
| Primary | Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 8 |
|
|
|
| Primary | Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 8 |
|
|
|
| Primary | Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 8 |
|
|
|
| Primary | Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 8 |
|
|
|
| Primary | Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 8 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 8 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 8 |
|
|
|
| Primary | Pain Measurement - Acyclic Pelvic Pain | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
| Primary | Pain Measurement - Pain Catastrophizing Score | 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). | Posted | Mean | 95% Confidence Interval | pain catastrophizing score | Week 12 |
|
|
|
| Primary | Pain Measurement - Pills | Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week. | Posted | Mean | 95% Confidence Interval | Pain pills per week | Week 12 |
|
|
|
| Primary | Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
| Primary | Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
| Primary | Quality of Life SF-12 MC | Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 12 |
|
|
|
| Secondary | Pain Measurement - Acyclic Pelvic Pain | 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). | Posted | Mean | Standard Deviation | VAS pain score | 6 months |
|
|
|
| Secondary | Pain Measurement - Acyclic Pelvic Pain | 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). | Posted | Mean | Standard Deviation | VAS pain score | 12 months |
|
|
|
| Secondary | Quality of Life EHP-30 | QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Quality of Life SF-12 PC | Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Primary | Inflammatory Markers | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 12 |
|
|
|
| Primary | Protein Measurement | Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 12 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 12 |
|
|
|
| Primary | Tumor Necrosis Factor Measurement #2 | Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan | Posted | Mean | 95% Confidence Interval | relative fluorescence units (RFU) | Week 12 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Participants in this arm will not receive the dietary intervention. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D000091662 | Genital Diseases |