Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Brief Symptom Inventory (BSI)
研究概览
简要总结
Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for GWI currently available, there is an urgent need to develop novel interventions to alleviate major GWI clinical complications. Recent evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants and common dietary preparations, in helping relieve clinical complications in Veterans with GWI. The overall goal is to test whether daily consumption of commercially available Concord grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and chronic fatigue in Veterans with GWI.
详细描述
Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits. Clinical complications of GWI typically persist over long-term, cause significant pain and suffering, and interfere with the ability of affected Veterans to successfully integrate back into civilian society. There is no treatment for GWI and there is an urgent need to develop novel interventions either to resolve underlying GWI mechanisms, or to alleviate major GWI clinical complications.
Recent Evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols that are abundantly found in some plants and common dietary preparations may help alleviate chronic fatigue and preserve cognitive functions. Based on this, the overall goal is to test whether the potential efficacy of dietary supplementation with a commercially available flavonoid-rich product, alleviates clinical complications in Veterans with GWI. In particular, the researchers propose a randomized, double-blind, placebo-controlled Phase I/IIA study to test the feasibility and potential efficacy of Concord grape juice dietary supplementation to treat cognitive deficits and chronic fatigue in Veterans with GWI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gulf War Veterans deployed to the Persian Gulf theatre between August 1990 and August
- •GWI will be defined according to the Kansas Case Definition. The Kansas Case Definition identifies 6 symptom domains and requires endorsement of moderately severe and/or multiple symptoms in at least 3 of those domains. To meet the case definition, the Veterans must also indicate that each symptom first became problematic during or within one year of the Gulf War.
排除标准
- •Individuals not meeting the inclusion criteria for Gulf War deployment and definition of GWI, or with conditions that might interfere with their ability to report their symptoms (e.g., drug use) are excluded.
- •Additional exclusion criteria are current medical conditions that may explain the symptoms (diabetes, heart disease, among others) or significant current (in the past six months) unstable (requiring significant medication adjustments or hospitalization) psychiatric conditions, including suicidal or homicidal ideation, schizophrenia or bipolar disorder according to subject responses to the interview and review by the principal investigator.
- •Subjects who usually consume abnormally high contents of dietary polyphenol based on a self-reported diet diary will be excluded.
结局指标
主要结局
Brief Symptom Inventory (BSI)
时间窗: 6 months
to assess safety and tolerability to treatment. The test is a 53-item self report scale that uses the 5 point Likert scale.
The Chalder Fatigue Questionnaire
时间窗: 6 months
The Chalder Fatigue Questionnaire assess chronic fatigue. Each of the 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology
Patient Health Questionnaire-15 (PHQ-15)
时间窗: 6 months
to assess safety and tolerability to treatment. The Patient Health Questionnaire 15 (PHQ 15) is a validated measure of somatic symptom severity in functional somatic syndromes (FSS). Scale ranges from 0-30 (mild to severe).
California Verbal Learning Test-Second Edition (CVLT-II)
时间窗: 6 months
This test looks at cognitive functioning by assessing immediate recall and long-delayed recall.
次要结局
- Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Block Design Subtest(6 months)
- Brief Visuospatial Memory Test-Revised (BVMT-R)(6 months)
- the Trail Making Test (TMT)(6 months)
- the Conner's Continuous Performance Test-3 (CPT-3)(6 months)
- the Stroop Test(6 months)
- Halstead Category Test(6 months)
- Wechsler Adult Intelligence Scale (WAIS-IV)(6 months)
- Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span Subtest(6 months)
研究者
Giulio Maria Pasinetti
Professor
Icahn School of Medicine at Mount Sinai