An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Quality of Life Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Postmenopausal
- •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
研究组 & 干预措施
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.
干预措施: AHEI diet (Other)
Control
Participants in this arm will not receive the dietary intervention.
结局指标
主要结局
Quality of Life Questionnaire
时间窗: Week 12
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.
Pain Measurement
时间窗: Week 12
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 Survey
时间窗: Week 12
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.
Tumor Necrosis Factor Measurement
时间窗: Week 12
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
inflammatory Markers
时间窗: Week 12
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 and IL-1β.
Inflammatory Markers
时间窗: Week 8
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Protein Measurement
时间窗: Week 12
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Tumor Necrosis Factor Measurement #2
时间窗: Week 12
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pain
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan
Protein Measurement
时间窗: Baseline
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
时间窗: Baseline
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan
Tumor Necrosis Factor Measurement #2
时间窗: Baseline
Measurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan
Pain Measurement - Acyclic Pain
时间窗: Week 4
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
时间窗: Week 4
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
时间窗: Week 4
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
时间窗: Week 4
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
时间窗: Week 4
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.
Quality of Life SF-12 MC
时间窗: Week 4
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.
Inflammatory Markers
时间窗: Week 4
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan
Protein Measurement
时间窗: Week 4
Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Tumor Necrosis Factor Measurement
时间窗: Week 4
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
时间窗: Week 4
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pelvic Pain
时间窗: 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).
Protein Measurement
时间窗: Week 8
Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Pain Measurement - Pain Catastrophizing Score
时间窗: 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).
Pain Measurement - Pills
时间窗: Week 8
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
时间窗: Week 8
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
时间窗: Week 8
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.
Quality of Life SF-12 MC
时间窗: Week 8
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.
Tumor Necrosis Factor Measurement
时间窗: Week 8
Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Tumor Necrosis Factor Measurement #2
时间窗: Week 8
Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Pain Measurement - Acyclic Pelvic Pain
时间窗: 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).
Pain Measurement - Pain Catastrophizing Score
时间窗: Week 12
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
时间窗: Week 12
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
时间窗: Week 12
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
时间窗: Week 12
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.
Quality of Life SF-12 MC
时间窗: Week 12
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.
Inflammatory Markers
时间窗: Week 12
Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
次要结局
- Pain Measurement(12 months)
- Qualify of Life Questionnaire(6 months)
- Quality of Life Questionnaire(12 months)
- Pain Measurement - Acyclic Pelvic Pain(6 months)
- Pain Measurement - Acyclic Pelvic Pain(12 months)
- Quality of Life EHP-30(6 months)
- Quality of Life SF-12 PC(12 months)
研究者
Holly Harris
Principal Investigator
Fred Hutchinson Cancer Center