Glutathione vs. Curcumin Clinical Trial
- Registration Number
- NCT02848417
- Lead Sponsor
- South Florida Veterans Affairs Foundation for Research and Education
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
- HIV
- Hepatitis B and C
- Primary sleep disorders
- Steroids
- Immunosuppressives
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Liquid or Capsules Placebo Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap Liposomal Glutathione Glutathione 12 weeks 630mg orally twice a day Curcumin Curcumin 12 weeks 400mg orally twice a day
- Primary Outcome Measures
Name Time Method Biomarker response to therapy using a VO2 exercise test 12 weeks Goal is that both will prove safe for use in GWI patients
Biomarker response to therapy using cytokine panel 12 weeks Goal is that both will prove safe for use in GWI patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Miami VA Center
🇺🇸Miami, Florida, United States