Clinical trial NCT04259788: An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Official title: An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Diet
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-02-06
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Measurement
timeFrame: Baseline
measure: Pain Measurement
timeFrame: Baseline
measure: Pain Measurement
timeFrame: Baseline
measure: Quality of Life Questionnaire
timeFrame: Baseline
measure: Quality of Life Survey
timeFrame: Baseline
measure: Inflammatory Markers
timeFrame: Baseline
measure: Protein Measurement
timeFrame: Baseline
measure: Tumor Necrosis Factor Measurement
timeFrame: Baseline
measure: Tumor Necrosis Factor Measurement #2
timeFrame: Baseline
measure: Pain Measurement
timeFrame: Week 4
measure: Pain Measurement
timeFrame: Week 4
measure: Pain Measurement
timeFrame: Week 4
measure: Quality of Life Questionnaire
timeFrame: Week 4
measure: Quality of Life Survey
timeFrame: Week 4
measure: Inflammatory Markers
timeFrame: Week 4
measure: Protein Measurement
timeFrame: Week 4
measure: Tumor Necrosis Factor Measurement
timeFrame: Week 4
measure: Tumor Necrosis Factor Measurement #2
timeFrame: Week 4
measure: Pain Measurement
timeFrame: Week 8
measure: Pain Measurement
timeFrame: Week 8
measure: Pain Measurement
timeFrame: Week 8
measure: Quality of Life Questionnaire
timeFrame: Week 8
measure: Quality of Life Survey
timeFrame: Week 8
measure: Inflammatory Markers
timeFrame: Week 8
measure: Protein Measurement
timeFrame: Week 8
measure: Tumor Necrosis Factor Measurement
timeFrame: Week 8
measure: Tumor Necrosis Factor Measurement #2
timeFrame: Week 8
measure: Pain Measurement
timeFrame: Week 12
measure: Pain Measurement
timeFrame: Week 12
measure: Pain Measurement
timeFrame: Week 12
measure: Quality of Life Questionnaire
timeFrame: Week 12
measure: Quality of Life Survey
timeFrame: Week 12
measure: inflammatory Markers
timeFrame: Week 12
measure: Protein Measurement
timeFrame: Week 12
measure: Tumor Necrosis Factor Measurement
timeFrame: Week 12
measure: Tumor Necrosis Factor Measurement #2
timeFrame: Week 12
Secondary outcomes:
measure: Pain Measurement
timeFrame: 6 months
measure: Pain Measurement
timeFrame: 12 months
measure: Qualify of Life Questionnaire
timeFrame: 6 months
measure: Quality of Life Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Holly Harris
role: PRINCIPAL_INVESTIGATOR
References: