Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Quantitative urine biomarker levels.
研究概览
简要总结
The goal of this study is to use pain-specific urine biomarkers to evaluate how daily nutritional supplementation with biomarker guided formulas effect, quality of life and urinary biomarker scores in chronic pain patients. Assessing the effect of biomarker guided supplementation on pain specific biomarkers through changes in urinary biomarker scores may solidify the necessity for identifying deficiencies to create an individualized treatment plan for pain patients. This study aims to evaluate the effect of biomarker-guided supplementation on the three categories of urinary biomarkers using targeted ingredients specifically designed for oxidative stress, inflammation, and nerve health. This study provides subjects with one of three nutritional supplement formulas based on their specific urinary biomarker test results and assesses changes in their urinary biomarker levels and their quality of life as it relates to their pain over a 3-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously submitted a urinary biomarker sample and agreed to be contacted for research.
- •Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months.
- •Be able to take oral medication and/or be willing to adhere to the supplement regimen.
排除标准
- •Diagnosis of bacterial or viral infection during or 3 months prior to the study.
- •Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit.
- •A history of cancer within 5 years prior to screening visit.
- •Be pregnant or breast-feeding or have plans to become pregnant at any time during the study
- •Participant has a known sensitivity or allergy to any of the ingredients in the study products.
- •Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.
结局指标
主要结局
Quantitative urine biomarker levels.
时间窗: 1 and 3 months of supplementation.
Quantitative urine biomarker levels after 1 and 3 months of supplementation.
Quality-of-life measures.
时间窗: 1 month of supplementation, 3 months and at 3 month follow up.
Summary scores of quality-of-life measures, patient reported outcome measurement information system 29 (PROMIS-29); assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. For overall scoring of the test (i.e., adding each response) a higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function), meaning a worse outcome.
次要结局
- Anxiety symptoms.(1 month, 2 months, 3 months and at 3 month follow up.)
- Visual Analog Scale pain scores(1 month, 2 months, 3 months and at 3 month follow up.)
- Depression symptoms.(1 month, 2 months, 3 months and at 3 month follow up.)
- Sleep quality score(1 month, 2 months, 3 months and at 3 month follow up.)
- Profile of Mood States(1 month, 2 months, 3 months and at 3 month follow up.)
研究者
Joshua Gunn
Chief Science Officer
Ethos Research & Development