Clinical Trial: Glutathione vs. Curcumin Clinical Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin

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 Summary: 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.
Sponsor: South Florida Veterans Affairs Foundation for Research and Education

Current Primary Outcome:

• Biomarker response to therapy using a VO2 exercise test [ Time Frame: 12 weeks ]
  Goal is that both will prove safe for use in GWI patients
• Biomarker response to therapy using cytokine panel [ Time Frame: 12 weeks ]
  Goal is that both will prove safe for use in GWI patients

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: South Florida Veterans Affairs Foundation for Research and Education

Dates:
Date Received: July 6, 2016
Date Started: April 2016
Date Completion: January 2019
Last Updated: July 25, 2016
Last Verified: July 2016