Endometriosis
Conditions
Keywords
Diet
Brief summary
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.
Interventions
OTHERAHEI diet
Main intervention is the consumption of an AHEI diet for 12 weeks.
Sponsors
Fred Hutchinson Cancer Center
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurement - Acyclic Pain | Baseline to 12 weeks | 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). |
| Pain Measurement - Pain Catastrophizing | Baseline | 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). |
| Pain Measurement - Pills | Baseline | Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week. |
| Quality of Life EHP-30 | Baseline to 12 weeks | 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. |
| Quality of Life SF-12 MC | Baseline to 12 weeks | 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. |
| Quality of Life SF-12 PC | Baseline | 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. |
| Inflammatory Markers | Baseline | Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan |
| Protein Measurement | Baseline | Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan |
| Tumor Necrosis Factor Measurement | Baseline | Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan |
| Tumor Necrosis Factor Measurement #2 | Baseline | Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan |
| Pain Measurement - Acyclic Pelvic Pain | Week 8 | 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). |
| Pain Measurement - Pain Catastrophizing Score | Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurement - Acyclic Pelvic Pain | 6 months | 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). |
| Quality of Life EHP-30 | 6 months | 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. |
| Quality of Life SF-12 PC | 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHolly Harris
Fred Hutchinson Cancer Center
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.8 years STANDARD_DEVIATION 6.2 |
| Baseline acyclic pelvic pain | 7.1 units on a scale STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 9 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Multiple races | 5 Participants |
| Race/Ethnicity, Customized Not reported | 4 Participants |
| Race/Ethnicity, Customized White | 78 Participants |
| Sex/Gender, Customized Female | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed