Testing the Model: A Phase 1/11 Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
Technical Report,30 Sep 2016,29 Sep 2017
Nova Southeastern University Fort Lauderdale United States
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We propose to perform a phase III study comparing two nutraceuticals and placebo that target mediators identified in our prior dynamic modeling study of Gulf War Illness GWI. We will repeat the dynamic modeling before treatment and on therapy to assess our modeling and the impact of the interventions on the homeostatic networks we have identified, with an added focus on the glutathioneredox system. In our prior study Dynamic Modeling in GWI we used an exercise stress model rest, peak VO2, and 7 follow-up sampling points to measure the mediators of relapse in the context of their interactive homeostatic networks. We surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomicimmune function in these subjects as compared to GW era sedentary healthy controls. We applied an integrative systems based approach rooted in computational biology connecting gene expression and biomarkers to pathways and to symptomsin order to identify potential therapeutic targets as well as optimal strategies for manipulation of these targets. Using this data we have developed a virtual model of the illness, which we have used to identify potential therapeutic targets. The proposed project is directed at the validation of pharmacologic mediation of illness targets for GWI, identified using an integrative systems-based approach to the study of molecular and cellular markers.
- Anatomy and Physiology