Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Biomarker response to therapy using a VO2 exercise test
研究概览
简要总结
The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.
详细描述
In the Investigator's prior study "Dynamic Modeling in GWI", the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. The investigator's research team applied an integrative systems-based approach rooted in computational biology connecting gene expression and biomarkers to pathways and to symptoms in order to identify potential therapeutic targets as well as optimal strategies for manipulation of these targets. Using this data the investigator's research team has developed a virtual model of the illness, which has been used to identify potential therapeutic targets.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veterans with Gulf War Illness
- •35 to 70 years old
- •Good health by medical history prior to 1990
- •Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity
排除标准
- •Major depression with psychotic or melancholic features
- •Schizophrenia
- •Bipolar disorder
- •Delusional disorders
- •Dementias of any type
- •History or current alcohol abuse
- •History or current drug abuse
- •Current tobacco use
- •Organ failure
- •Defined rheumatologic
- •Inflammatory disorders
- •Hepatitis B and C
- •Primary sleep disorders
- •Immunosuppressives
研究组 & 干预措施
Curcumin
12 weeks 400mg orally twice a day
干预措施: Curcumin (Drug)
Liposomal Glutathione
12 weeks 630mg orally twice a day
干预措施: Glutathione (Drug)
Placebo Liquid or Capsules
Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml
Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap
干预措施: Placebo (Other)
结局指标
主要结局
Biomarker response to therapy using a VO2 exercise test
时间窗: 12 weeks
Goal is that both will prove safe for use in GWI patients
Biomarker response to therapy using cytokine panel
时间窗: 12 weeks
Goal is that both will prove safe for use in GWI patients
次要结局
未报告次要终点
研究者
Nancy Klimas
M.D
South Florida Veterans Affairs Foundation for Research and Education