Development of Dietary Polyphenol Preparations for Treating Veterans with Gulf War Illness
Technical Report,30 Sep 2017,29 Sep 2018
Icahn School of Medicine at Mount Sinai (ISMMS) New York United States
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There are no treatments for Gulf War Illness GWI and there is an urgent need to develop novel interventions either to resolve underlying GWI mechanisms, or to alleviate major GWI clinical complications, particularly chronic fatigue, cognitive difficulties, muscle pain, as well as mood disturbances and sleep problems. Recent evidence from our group and from others revealed that certain dietary flavonoids may promote cognitive function andor alleviate chronic fatigue. We hypothesized that dietary supplementation with a Flavonoid Rich Preparation FRP, a combination of Concord Grape Juice CGJ and Grape Seed Polyphenolic Extract GSPE may help alleviate clinical complications of GWI, particularly chronic fatigue andor cognitive dysfunction. We propose to test the feasibility of dietary supplementation with FRP in Veterans with GWI, and to gather evidence supporting the efficacy of FRP in alleviating GWI-associated cognitive deficits and chronic fatigue. Purpose To conduct a randomized, double-blind Phase IIIA study to explore long-term dose compliance, safety, tolerability of FRP and to assess the efficacy of FRP in improving cognition function and alleviating chronic fatigue in Veterans with GWI. Scope Evidence gathered by our proposed studies will provide the necessary proof of principle data and support future development of broader efficacy studies of a specific, readily available nutritional supplementation regimen, FRP, for treating Veterans with GWI. Progress In fiscal year 3, we continued recruitment through the DMDC generated database by sending introductory letters accompanied by follow-up calls two weeks later. Due to financial constraints, we closed the protocol to new enrollment on July 19th, 2018 the date of VANJHCS Continuing Review. At the time of study closure, we had sent letters to 777 potential participants. Of those 777, we screened 72 potential participants with 46 of them screening eligible.
- Medicine and Medical Research
- Food, Food Service and Nutrition