Development of Dietary Polyphenol Preparations for Treating Veterans with Gulf War Illness

Abstract

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 asmood disturbances and sleep problems. Recent evidence from our group and from others revealed that certain dietary flavonoids may promote cognitive function and/or alleviate chronic fatigue. We hypothesized that dietary supplementation with a Flavonoid Rich Preparation(FRP), consisting of Concord Grape Juice (CGJ), may help alleviate clinical complications of GWI, particularly chronic fatigue and/or 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 I/IIA 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 5, we completed data collection for all participants consented prior to the enrollment closure date of July 19th, 2018. The final endpoint was completed on January 17th, 2019 and data analysis began shortly afterward. We are currently creating a manuscript describing our results to submit for publication in the future. To summarize our final enrollment numbers, we sent letters to 777 potential participants. Of those 777, we screened 72 potential participants with 46 of them screening eligible.

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Document Details

Document Type
Technical Report
Publication Date
Dec 01, 2019
Accession Number
AD1093983

Entities

People

  • Giulio Maria Pasinetti

Organizations

  • Icahn School of Medicine at Mount Sinai

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Biomedical Research
  • Cognition
  • Data Analysis
  • Department Of Defense
  • Department Of Veterans Affairs
  • Dysfunction
  • Electronic Mail
  • Health Care
  • Information Operations
  • Intervention
  • Low Temperature
  • New Jersey
  • New York
  • Patent Applications
  • Persian Gulf Syndrome
  • Professional Development
  • Technology Transfer

Readers

  • Clinical Trial Research.
  • Gulf War Illness and Chronic Multisymptom Illness in Veterans.